Intragastric device for treating obesity

ABSTRACT

A gastrointestinal device for treating obesity includes a three-dimensional porous structure configurable between a compressed pre-deployment configuration to facilitate delivery and an expanded post-deployment configuration. The porous structure includes a first opening at its proximal end and a larger second opening at its distal end. The porous structure also includes a sleeve coupled to its distal end. Optionally, the device further includes a suture at the proximal end of the wire mesh structure to facilitate retrieval and an anti-migration component positioned at the junction of the porous structure with the sleeve. The porous structure is deployed in a patient&#39;s stomach such that the anti-migration component sits proximal to the patient&#39;s pylorus and prevents migration of the entirety of the device into and through the pylorus. The sleeve extends through the pylorus, into the duodenum and ends in the duodenum or jejunum. Food enters the device from the first opening at the proximal end of the porous structure, passes through the porous structure and sleeve, and exits at the distal end of the sleeve. The device treats obesity by providing a relatively immovable volume occupying structure in the stomach and a bypass for food past the pylorus and proximal portion of the small intestine. Optionally, the device further acts to slow the passage of food through the digestive tract. Patients with the device experience satiety more quickly and have a prolonged sensation of satiety.

CROSS-REFERENCE

The present application relies on U.S. Provisional Patent ApplicationSer. Nos. 61/884,981, entitled “Gastrointestinal Device for TreatingObesity” and filed on Sep. 30, 2013, and 61/782,564, entitled“Intragastric Device for Treating Obesity” and filed on Mar. 14, 2013,for priority.

The present application is also a continuation of U.S. patentapplication Ser. No. 15,353,219, entitled “INTRAGASTRIC DEVICE FORTREATING OBESITY,” filed on Nov. 16, 2016, which is a continuation ofSer. No. 14/214,609, of the same title, filed on Mar. 14, 2014, now U.S.Pat. No. 9,526,648, which is a continuation-in-part of U.S. patentapplication Ser. No. 14/096,505, of the same title, filed on Dec. 4,2013, now U.S. Pat. No. 10,413,436, which is a continuation applicationof U.S. patent application Ser. No. 12/814,481, of the same title, filedon Jun. 13, 2010, now U.S. Pat. No. 8,628,554.

All of the above applications are herein incorporated by reference intheir entirety.

FIELD

The present specification relates generally to medical devices useful inthe treatment of obesity. More particularly, the present specificationrelates to intragastric and gastrointestinal devices of dynamic weightthat reduce gastric volume, slow gastric emptying, and/or bypassportions of the small intestine, thereby leading to patient weight loss.

BACKGROUND

Obesity is a common condition and growing public health problem indeveloped nations including the United States. As of 2009, more than twothirds of American adults, approximately 127 million people, were eitheroverweight or obese. Over one third of American adults are obese. Datasuggest that 300,000 Americans die prematurely from obesity-relatedcomplications each year. Many children in the United States are alsoeither overweight or obese. Hence, the overall number of overweightAmericans is expected to rise in the future. It has been estimated thatobesity costs the United States over $100 billion annually in direct andindirect health care expenses and in lost productivity. This trend isalso apparent in many other developed nations.

For adults, the body mass index (BMI) is used to determine if one isoverweight or obese. A person's BMI is calculated by multiplying bodyweight in pounds by 703 and then dividing the total by height in inchessquared. A person's BMI is expressed as kilograms per meter squared. Anadult is considered overweight if his or her BMI is between 25 and 30kg/m2. Obesity is defined as possessing a BMI between 30 and 40 kg/m2. ABMI greater than 30 kg/m2 is associated with significant co-morbidities.Morbid obesity is defined as possessing either a body weight more than100 pounds greater than ideal or a BMI greater than 40 kg/m2.Approximately 5% of the U.S. population meets at least one of thecriteria for morbid obesity. Morbid obesity is associated with manydiseases and disorders including, for example: diabetes; hypertension;heart attack; stroke; dyslipidemia; sleep apnea; pickwickian syndrome;asthma; lower back and disc disease; weight-bearing osteoarthritis ofthe hips, knees, ankles and feet; thrombophlebitis and pulmonary emboli;intertriginous dermatitis; urinary stress incontinence; gastroesophagealreflux disease (GERD); gallstones; and, sclerosis and carcinoma of theliver. In women, infertility, cancer of the uterus, and cancer of thebreast are additionally associated with morbid obesity. Taken together,the diseases associated with morbid obesity markedly reduce the odds ofattaining an average lifespan. The sequelae raise annual mortality ratesin affected people by a factor of 10 or more.

Current treatments for obesity include diet, exercise, behavioraltreatments, medications, surgery (open and laparoscopic), and endoscopicdevices. New drug treatments for obesity are currently being evaluatedin clinical trials. However, a high efficacy pharmaceutical treatmenthas not yet been developed. Further, short-term and long-term sideeffects of current pharmaceutical treatments often concern consumers,pharmaceutical providers, and/or their insurers. Generally, diet or drugtherapy programs have been consistently disappointing, failing to bringabout significant, sustained weight loss in the majority of morbidlyobese people.

Currently, most operations used to treat morbid obesity include gastricrestrictive procedures, involving the creation of a small (e.g., 15-35ml) upper gastric pouch that drains through a small outlet (e.g.,0.75-1.2 cm), setting in motion the body's satiety mechanism. About 15%of operations used to treat morbid obesity performed in the UnitedStates involve combining a gastric restrictive procedure with amalabsorptive procedure. Typical malabsorptive procedures divide smallintestinal flow into a biliary-pancreatic conduit and a food conduit.Potential long-term side effects associated with abdominal surgicalprocedures include herniation and small bowel obstruction. In addition,long-term problems specific to bariatric procedures also include gastricoutlet obstruction, marginal ulceration, protein malnutrition, andvitamin deficiency.

Other surgical strategies for treating obesity include endoscopicprocedures, many of which are still in development. Endoscopicprocedures and devices to produce gastric pouch and gastrojejunalanastomosis are used to replicate laparoscopic procedures.Endoscopically placed gastric balloons restrict gastric volume andresult in satiety with smaller meals. For example, U.S. patentapplication Ser. No. 10/221,562, now issued as U.S. Pat. No. 7,172,613and assigned to Districlass Medical SA, describes an “intragastricdevice inserted by endoscopic path into a patient's stomach. The deviceincludes a balloon or envelope having a specific nominal volume. Theballoon is sealingly connected to connecting elements consisting of adisc forming a support base for the balloon against an inner wall of thestomach. The device also includes a flexible tube or catheter forconnecting the balloon to a filling device and catching element integralwith the tube or catheter. The connection elements enable a doctor toset and/or remove the balloon and to fix, either inside the patient'sbody, or subcutaneously the filling device and to be able to bring theballoon or envelope to its predetermined nominal volume.”

The silicone intragastric balloon (IGB) has been developed as atemporary aid to achieve weight loss specifically for people who weigh40% or more of their ideal weight and who have had unsatisfactoryresults in their treatment of obesity, despite being cared for by amultidisciplinary team. This treatment is also indicated for morbidlyobese patients who have a high morbidity and mortality risk for surgery.The placement and removal of the IGB is an endoscopic procedure and theballoon is designed to float freely inside the stomach. The IGBtechnique reduces the volume of the stomach and leads to a prematurefeeling of satiety. However, use of IGBs did not show convincingevidence of a greater weight loss. The relative risks for minorcomplications, for example, gastric ulcers and erosions, weresignificantly raised. All inflatable IGB devices suffer from the problemof deterioration of the balloon over time. This deterioration can resultin deflation with loss of efficacy and complications such as small bowelobstruction secondary to balloon migration. Due to loss of efficacy overtime, IGB devices are recommended only for short (<6 month) durations.In addition, rapid inflation of the balloon poses the risk of esophagealor gastric perforations, both of which are surgical emergencies. Deathshave been reported in patients using IGB treatment.

Endoscopic procedures are also used to deploy mesh structures into thestomach in an effort to occupy stomach volume and create the artificialsensation of being full. For example, U.S. patent application Ser. No.11/657,231, assigned to Wilson-Cook Medical, Inc., describes an“intragastric device generally compris[ing] a strip digestive-resistantmesh material that is operable between a first configuration and asecond configuration. The first configuration is sufficiently small topermit introduction of the digestive-resistant mesh material into agastric lumen of the mammal. The second configuration is sufficientlylarge to prevent the digestive-resistant mesh material from passingthrough the mammal's pylorus, thereby permitting the mesh member to actas an artificial bezoar.”

Although endoscopically placed balloon structures can be effective, theyare not without their associated risks and complications. Meshstructures are effective in occupying available gastric volume but theydo not address gastric emptying. Migration and small bowel obstructionfrom such devices continue to remain a significant problem. Therefore, aneed exists for an intragastric device to treat obesity that combinesthe benefits obtained through reducing stomach volume, slowing gastricemptying, and providing a bypass for food past the pylorus and a portionof the small intestine, while remaining relatively safe. The deviceshould also include a component for preventing migration of the entiredevice out of the stomach. This device should limit side effects and beable to be deployed and removed in a non-invasive manner with relativeease. In addition, this device should have the option of furthertreating obesity by including the benefits obtained by malabsorptivediversion procedures. The addition of this optional benefit would makethe device effective in treating not only obesity, but type II diabetesas well.

Typical metal structures cannot survive the hostile environment,particularly with respect to the high acidity, of the stomach.Intragastric devices comprising acid-sensitive components, such as metalwires, are typically covered or coated in an acid-resistant material(i.e. silicone) to prevent degradation of these components by acidicgastric contents. Conventional manufacturing processes for creatingthese coated intragastric devices first coat the metal wires of thedevice and then form the wires into the desired end shape of the device.As the shapes and structures of intragastric devices become morecomplicated, these conventional processes are unable to properly createthe desired end product. A shape memory metal, such as Nitinol, isheat-set at temperatures in excess of 400° C. Coating the metal with anacid-resistant material and then heat-setting into the final shape wouldresult in destruction of the coating during exposure to the hightemperatures. Therefore, a method of manufacture is needed wherein thewires of the intragastric device are first formed into the desired endshape and are then coated with a corrosion-resistant material. Such amethod will take care to prevent the coating and covering or clogging ofthe spaces or openings between the wires of the wire mesh. Such a methodwill also produce a finished device that is still flexible enough to beconverted from a compressed, first pre-deployment shape to an expanded,post-deployment shape.

Specific surgical options for the treatment of obesity also includelaparoscopic sleeve gastrectomy (LSG) and laparoscopic roux-en-y-gastricbypass (RGB) surgery. Gastrectomy refers to a partial or full surgicalremoval of the stomach. LSG is a restrictive treatment, surgicalweight-loss procedure in which the stomach is reduced to approximately25% of its original size by surgical removal of a large portionfollowing the major curve. The open edges are then attached together(often with surgical staples) to form a sleeve or tube with a bananashape. The procedure permanently reduces the size of the stomach. Theprocedure is performed laparoscopically and is not reversible. Followingthe operation, the stomach empties its contents rapidly into the smallintestine, but with little or no vomiting (characteristic of otherrestrictive procedures).

LSG involves a longitudinal resection of the stomach on the greatercurvature from the antrum starting opposite the nerve of Latarjet up tothe angle of His. The first step of the procedure is the division of thevascular supply of the greater curvature of the stomach which isachieved with the section of the gastro-colic and gastro-splenicligaments close to the stomach. The greater curvature is completelyfreed up to the left crus of the diaphragm to resect the gastric fundusthat harbors the ghrelin secreting cells of the stomach. The second stepof the procedure is the longitudinal gastrectomy that “sleeves” thestomach to reduce its shape to a narrow tube. The pylorus and part ofthe antrum are preserved, resulting in a lesser curvature-based“restrictive” gastric sleeve.

Sleeve gastrectomy (also called gastric sleeve) is usually performed onextremely obese patients, with a body mass index of 40 or more, wherethe risk of performing a gastric bypass or duodenal switch procedure maybe too large. A two-stage procedure is performed: the first is a sleevegastrectomy; the second is a conversion into a gastric bypass orduodenal switch. Patients usually lose a large quantity of their excessweight after the first sleeve gastrectomy procedure but, if weight lossceases, the second step is performed.

For patients that are obese but not extremely obese, sleeve gastrectomyalone is a suitable operation with minimal risks. The sleeve gastrectomyis currently an acceptable weight loss surgery option for obese patientsas a single procedure. Most surgeons prefer to use a bougie (taperingcylindrical instrument) having an outer diameter between 32-60 French(the optimal bougie size is 32 Fr-36 Fr) with the procedure. The idealapproximate remaining capacity of the stomach after the procedure is 15ml.

One of the mechanisms involved in weight loss observed after the LSG isthe dramatic reduction of the capacity of the stomach. The concept ofrestriction has been widely used in bariatric surgery in vertical bandedgastroplasty (VBG) and laparoscopic adjustable gastric banding (LAGB).The distension of the small gastric pouch in the LAGB procedure or VBGis intended to account for the feeling of early fullness, enhancedsatiety and decreased hunger experienced by a patient after theingestion of small quantities of food.

The hormonal modifications induced by LSG differ from those found aftera purely restrictive procedure such as LAGB. Ghrelin, a peptide hormonemainly produced in the fundus of the stomach, is believed to be involvedin the mechanisms regulating hunger. There is a significant reduction inghrelin associated with resection of the gastric fundus.

What makes LSG a preferable option lies in the fact that the operationis a straightforward procedure that can generally be completedlaparoscopically, even in the case of an extremely obese patient. Itdoes not involve any digestive anastomosis and no mesenteric defects arecreated, eliminating the risk of internal hernia. In addition, noforeign material is used as in the case of gastric banding, the wholedigestive tract remains accessible to endoscopy, and it is notassociated with Dumping syndrome. Also, the risk of peptic ulcer is lowand the absorption of nutrients, vitamins, minerals and drugs is notaltered.

Early reports of LSG have shown it to be safe and effective with markedweight loss and significant reduction of major obesity-relatedcomorbidities. The question whether LSG may work as a sole bariatricprocedure in the long term cannot yet be answered. For this reason, LSGis proposed as the first step of a staged approach in patients for whoma biliopancreatic diversion with duodenal switch (BPD-DS) or RGB seemstoo hazardous because of a very high BMI (super obesity=BMI>50 orsuper-super obesity=BMI>60) and/or associated diseases whether relatedor not to obesity.

Laparoscopic roux-en-y-gastric bypass (RGB) involves the creation of asmall (20-30 ml) gastric pouch and a Roux limb (typically 75-105 cm)that reroutes a portion of the alimentary tract to bypass the distalstomach and proximal small bowel. Following RGB, a pleiotropic endocrineresponse may contribute to improved glycemic control, appetitereduction, and long-term changes in body weight. RGB also has aprofoundly positive impact on obesity-related comorbidities and qualityof life. Other advantages include established long-term effectivenessfor sustained weight loss, reduction of comorbidities, minimal risk forlong-term nutritional sequelae, and effective relief of gastroesophagealreflux disease (GERD). RGB is not without risks. Common causes of deathinclude pulmonary embolism and anastomotic leaks. Nonfatal perioperativecomplications include anastomotic leaks, venous thromboembolism, woundinfections, small bowel obstruction, and bleeding. Postoperativegastrointestinal complications include nausea and vomiting,micronutrient deficiencies, and possible weight regain.

Failures after these bariatric procedures are common and patients startregaining weight or the progressive weight loss stops at asub-therapeutic level. Therefore, there is a need for salvage therapyafter one or more failed bariatric procedures. What is needed is adevice to be used following bariatric surgery that will combine thebenefits of gastric volume reduction, bilio-pancreatic diversion and/orintestinal bypass to enhance the weight loss effects of the device. Whatis also needed is a device that will further reduce the volume of asurgically restricted stomach to reduce the amount of calories that canbe consumed. The device will also bypass the proximal small intestine orthe roux limb of the intestine in order to produce intestinal malabsorption, bilio-pancreatic diversion or both. The device can furtheract to delay gastric emptying, release the gastric hormones associatedwith satiety, and stimulate the gastric nerves associated with sensationof satiety. The device could be combined with other therapeutic agentssuch as electrical stimulation, magnetic stimulation, or pharmaceuticalagents.

The device can be used as a primary therapeutic procedure for weightloss or as a bridge to surgery for a definitive weight loss procedure.The device may also be used in the treatment of other conditionsincluding, but not limited to, metabolic syndrome, diabetes mellitus,dyslipidemias and cardiovascular disease.

SUMMARY

The present specification discloses an intragastric device comprising: aporous structure comprising a top, a bottom, and an interior and havinga pre-deployment shape with a first volume and a post-deployment shapewith a second volume greater than said first volume, wherein, in saidpost-deployment shape, said porous structure includes at least one firstopening proximate said top and at least one second opening proximatesaid bottom such that food enters said porous structure through said atleast one first opening, passes through said interior, and exits saidporous structure through said at least one second opening; and a sleevehaving a flexible elongate body, a proximal end with a third opening, adistal end with a fourth opening, and a sleeve interior, wherein saidsleeve is coupled to said porous structure such that food exiting saidat least one second opening enters said sleeve through said thirdopening, passes through said sleeve interior, and exits said sleevethrough said fourth opening.

In one embodiment, said at least one first opening does not direct foodinto said sleeve interior such that food exiting said interior of saidporous structure through said at least one first opening does not entersaid sleeve and said at least one second opening does direct food intosaid sleeve interior such that food exiting said interior of said porousstructure through said at least one second opening does enter saidsleeve. In one embodiment, a first surface area defined by said at leastone first opening is greater than a second surface area defined by saidat least one second opening. In another embodiment, a first surface areadefined by said at least one first opening is less than a second surfacearea defined by said at least one second opening. In yet anotherembodiment, a first surface area defined by said at least one firstopening is substantially equal to a second surface area defined by saidat least one second opening.

In various embodiments, said at least one first opening has a diameterof 50 mm or less.

In various embodiments, said at least one second opening has a diameterof 100 mm or less.

In various embodiments, said pre-deployment shape is at least one oflinear, cylindrical, or conical.

In various embodiments, when in said pre-deployment configuration, saiddevice has a diameter or 25 mm or less.

In various embodiments, said post-deployment shape of said porousstructure is at least one of an expanded cylinder, ovoid, sphere, bean,stomach shape, football, cube or cuboid.

In various embodiments, when in said post-deployment configuration, saidporous structure occupies at least 10% of a patient's stomach volume.

In various embodiments, when is said post-deployment configuration, saidporous structure has a volume of at least 100 mL.

In various embodiments, when in said post-deployment configuration, thediameter of said porous structure is greater than the diameter of anopen pylorus.

In various embodiments, when in said post-deployment configuration, saiddevice is capable of moving no more than 15 inches proximally, distally,and laterally within a patient's stomach.

In various embodiments, when in said post-deployment configuration, saidporous structure has a width within a range of 1 cm to 25 cm and alength within a range of 1 cm to 25 cm.

In various embodiments, the porous structure comprises at least one of awire mesh structure, a spiral wire structure, a spiral strip structure,or a lattice structure. In one embodiment, said wire mesh structurecomprises mesh openings between the wires of said wire mesh structurewherein the average size of said mesh openings is greater than 1 mm indiameter. In various embodiments, when in said post-deploymentconfiguration, the wires of said wire mesh structure comprise 50% orless of the surface area of said wire mesh structure and openingsbetween said wires comprise the remaining surface area. In variousembodiments, said wire mesh has a plurality of vertical and horizontalelements which, when expanded, create the at least one first opening andthe at least one second opening. In various embodiments, said wire meshvertical and horizontal elements comprise at least one of a metal, analloy, a polymer, a shape memory metal, or a shape memory polymer.

In one embodiment, when in said post-deployment configuration, the wiremesh structure has a length from its proximal end to its distal end thatis greater than a width of the wire mesh structure that extends, at themidpoint between said proximal end and said distal end, from one side ofsaid wire mesh structure to the opposite side of said wire meshstructure. In another embodiment, when in said post-deploymentconfiguration, the wire mesh structure has a length from its proximalend to its distal end that is equal to a width of the wire meshstructure that extends, at the midpoint between said proximal end andsaid distal end, from one side of said wire mesh structure to theopposite side of said wire mesh structure. In yet another embodiment,when in said post-deployment configuration, the wire mesh structure hasa length from its proximal end to its distal end that is less than awidth of the wire mesh structure that extends, at the midpoint betweensaid proximal end and said distal end, from one side of said wire meshstructure to the opposite side of said wire mesh structure.

In one embodiment, when in said post-deployment configuration, said wiremesh structure comprises a wire mesh weave pattern which makes the wiremesh structure more easily compressible along the vertical axis. Inanother embodiment, when in said post-deployment configuration, saidwire mesh structure comprises a wire mesh weave pattern which makes thewire mesh structure more easily compressible along the horizontal axis.

In one embodiment, when in said post-deployment configuration, said wiremesh structure comprises a wire mesh weave pattern which provides aconsistent radial strength throughout said wire mesh structure, furtherwherein said radial strength is greater than the compressive force of apatient's stomach.

In various embodiments, when in said post-deployment configuration, saidwire mesh structure comprises an upper portion extending from saidproximal end to a middle point halfway between said proximal end andsaid distal end and a lower portion extending from said distal end to amiddle point halfway between said proximal end and said distal end.Optionally, in one embodiment, said upper portion comprises a first wiremesh weave pattern which provides said upper portion with a radialstrength greater than the radial strength provided to the lower portionby a second wire mesh weave pattern of said lower portion. Optionally,in another embodiment, said upper portion comprises a wire mesh weavepattern which provides said upper portion with a radial strength greaterthan the compressive force of a patient's stomach and said lower portioncomprises a flexible membrane.

In one embodiment, said wire mesh structure further comprises amechanism which is designed to be manually engaged when said device isin said post-deployment configuration wherein said mechanism providessaid wire mesh structure with a radial strength greater than thecompressive force of a patient's stomach. In various embodiments, saidmechanism comprises any one or combination of a rod, radial spokes, adisc, or a separate device within said wire mesh structure.

In one embodiment, said device is self-expanding and said expansion iseffectuated through the use of a shape memory metal. In one embodiment,said shape memory metal is Nitinol.

In one embodiment, said device is self-expanding and said expansion iseffectuated through the use of a temperature sensitive material.

In one embodiment, the shape of said device is changed from saidpre-deployment shape to said post-deployment shape by the use of anexpansion tool.

In various embodiments, said porous structure in enveloped by apartially perforated membrane having a membrane surface area. In variousembodiments, said membrane comprises at least one of silicone, latex,parylene, polyurethane, polytetrafluoroethylene (PTFE), expandedpolytetrafluoroethylene (PTFE), fluorinated ethylene-propylene, Dacron,or Polyethylene terephthalate (PET). In one embodiment, said membrane issubstantially non-porous. In other embodiments, said membrane has aspecific level of porosity.

In various embodiments, said membrane has at least one first membraneopening positioned proximate said top of said porous structure anddefining a first membrane opening surface area and at least one secondmembrane opening positioned proximate said bottom of said porousstructure and defining a second membrane opening surface area. In oneembodiment, said first membrane opening surface area is greater thansaid second membrane opening surface area. In another embodiment, saidfirst membrane opening surface area is less than said second membraneopening surface area. In yet another embodiment, said first membraneopening surface area is substantially equal to said second membraneopening surface area.

In various embodiments, a sum of said first membrane opening surfacearea and said second membrane opening surface area is between one andninety-nine percent of the membrane surface area.

In various embodiments, said at least one first membrane opening and/orat least one said second membrane opening has at least one valve thatcontrols a directionality of flow of food or nutrients in and out of theporous structure.

In various embodiments, said at least one first membrane opening ispositioned to align with said at least one first opening of said porousstructure and said at least one second membrane opening is positioned toalign with said at least one second opening of said porous structure.

Optionally, in one embodiment, said device is attached to a catheter,wherein said catheter is configured to induce a change from thepre-deployment shape to said post-deployment shape.

Optionally, in various embodiments, the intragastric device furthercomprises a second porous structure attached to said top of saidexisting porous structure. In one embodiment, said second porousstructure is smaller than said existing porous structure. In anotherembodiment, said second porous structure is larger than said existingporous structure. In yet another embodiment, said second porousstructure is substantially the same size as said existing porousstructure.

Optionally, in various embodiments, said porous structure is coated witha corrosion-resistant material preventing exposure of said porousstructure to gastric acid, wherein said corrosion-resistant materialcovers said porous structure and does not cover said openings of saidporous structure. In various embodiments, said corrosion-resistantmaterial comprises any one or combination of silicone, polyester,polyether ether ketone (PEEK), a medical grade epoxy, ceramic, or metal.

Optionally, in various embodiments, the intragastric device furthercomprises at least one circumferential constricting mechanism positionedabout said porous structure.

Optionally, in various embodiments, said porous structure furtherincludes a radiopaque marker to facilitate delivery using radiographicvisualization.

Optionally, in various embodiments, the intragastric device furthercomprises at least one sensor. In various embodiments, said sensorcomprises any one or combination of a flow or impedance sensor, aglucose sensor, a temperature sensor, a pH sensor, and an accelerometer.

In various embodiments, said sleeve has a length sufficient to extendfrom said bottom of said porous structure, through a patient's pylorusand duodenum, and into the patient's jejunum.

In various embodiments, said sleeve is comprised of a corrosiveresistant and biocompatible material. In various embodiments, saidsleeve comprises at least one of silicone, latex, parylene,polyurethane, polytetrafluoroethylene (PTFE), expandedpolytetrafluoroethylene (PTFE), fluorinated ethylene-propylene, Dacron,or Polyethylene terephthalate (PET).

Optionally, in one embodiment, said fourth opening of said sleeve ispositioned on said elongate body proximal to said distal end and saidsleeve further comprises a pouch at said distal end beyond said fourthopening.

Optionally, in one embodiment, said fourth opening of said sleeve ispositioned at said distal end of said sleeve.

In various embodiments, said sleeve has a length within a range of 6inches to 120 inches. In one embodiment, said sleeve has a length of 24inches.

In various embodiments, said sleeve has a diameter within a range of 1cm to 10 cm. In one embodiment, said sleeve has a diameter of 3 cm.

In one embodiment, said distal end of sleeve is weighted to maintainsleeve in an elongate shape.

In various embodiments, said sleeve is coupled to said porous structurevia sutures or glue or is thermally fused to said porous structure. Inone embodiment, said device further includes an adapter coupling saidsleeve with said porous structure.

In one embodiment, said sleeve is coupled via at least one couplingmechanism to said porous structure at a distance distally away from saidporous structure.

In one embodiment, the intragastric device further comprises a secondsleeve wherein said second sleeve comprises a flexible elongate bodyhaving a proximal end, a distal end, and a lumen within, a fifth openingat said proximal end, and a sixth opening proximate said distal endwherein said fifth opening of said second sleeve and a diameter of saidsecond sleeve are greater than or equal to the diameter of said firstsleeve, further wherein said first sleeve is coupled directly to saidporous structure and said second sleeve is coupled via at least onecoupling mechanism to said porous structure at a distance distally awayfrom said porous structure, further wherein said distal end of saidfirst sleeve extends through said fifth opening of said second sleevesuch that said fourth opening of said first sleeve opens into said lumenof said second sleeve.

In various embodiments, said sleeve comprises a flexible coil or meshhaving a weave pattern which provides the sleeve with anti-torsionalproperties and structural support such that said sleeve remains in anelongate shape.

In various embodiments, said sleeve comprises a membrane having aplurality of horizontal and vertical support elements which provide thesleeve with anti-torsional properties and structural support such thatsaid sleeve remains in an elongate shape. In various embodiments, saidhorizontal support elements are spaced between 1 inch and 24 inchesapart from one another and said vertical support elements are between 1inch and 60 inches in length.

In various embodiments, said horizontal support elements are spaced 6inches apart from one another and said vertical support elements are 6inches in length.

In various embodiments, said sleeve comprises a membrane having a spiralmetal wire extending its entire length which provides the sleeve withanti-torsional properties and structural support such that said sleeveremains in an elongate shape.

In one embodiment, said sleeve is capable of telescoping into itself.

In one embodiment, said sleeve comprises a membrane and said membrane ofsaid sleeve extends onto a portion of said porous structure.

In one embodiment, said sleeve further comprises a radiopaque marker tofacilitate delivery using radiographic visualization.

In one embodiment, the intragastric device further comprises a retrievalmechanism fixedly attached to the top of said porous structure. Invarious embodiments, said retrieval mechanism comprises a suture or wirehaving a loop shape.

Optionally, in various embodiments, the intragastric device furthercomprises an anti-migration component positioned at the junction of saidporous structure and said sleeve and attached to said porous structureor said sleeve or both, wherein said anti-migration component comprisesa compressed pre-deployment configuration and an expandedpost-deployment configuration and is designed to sit proximal to apatient's pylorus and prevent migration of the porous structure into andthrough said pylorus.

In various embodiments, when in said pre-deployment configuration, saidanti-migration component has a shape comprising any one of linear,cylindrical, or conical.

In various embodiments, when in said post-deployment configuration, saidanti-migration component has a shape comprising any one of donut,discoid sloping proximally, discoid sloping proximally, flat discoid orcircular, a half bumper, a full bumper, a flower shape, or a saucershape.

In one embodiment, when in said post-deployment configuration, saidanti-migration component has a width that is greater than the diameterof the porous structure.

In one embodiment, when in said post-deployment configuration, saidanti-migration component has a radial strength that is greater than thecompressive force of a patient's stomach.

In one embodiment, said anti-migration component is comprised of metal.In one embodiment, said metal is a shape memory metal. In oneembodiment, said shape memory metal is Nitinol. In another embodiment,said metal is temperature sensitive.

Optionally, in one embodiment, anti-migration component is coated with acorrosive resistant material. In various embodiments, said corrosiveresistant material is any one or combination of silicone, polyester, amedical grade epoxy, ceramic, or metal.

In one embodiment, said anti-migration component further includes aradiographic marker to facilitate delivery using radiographicvisualization.

The present specification also discloses a method for manufacturing aporous structure for an intragastric device, said porous structurecomprising a top, a bottom, and an interior and having a pre-deploymentshape with a first volume and a post-deployment shape with a secondvolume greater than said first volume, wherein, in said post-deploymentshape, said porous structure includes at least one first openingproximate said top and at least one second opening proximate saidbottom, said method comprising the steps of: heat-setting at least oneflexible metal wire or strip having memory shape properties into saidporous structure having said post-deployment shape; dipping the entiretyof said porous structure into a corrosion-resistant material that hasbeen heated to a liquid state; removing said porous structure from saidcorrosion-resistant material; allowing corrosion-resistant materialpresent on said porous structure after said dipping and removing to airdry into a solid state; and, repeating the steps of dipping said porousstructure into said corrosion-resistant material, removing said porousstructure from said corrosion-resistant material, and allowing corrosionresistant-material to air dry, until a corrosion-resistant materialcoating having a desired thickness has been deposited onto said porousstructure.

In various embodiments, when in said post-deployment configuration, aplurality of spaces create in said porous structure each has a diameterof 2-20 mm.

In various embodiments, said corrosion-resistant material comprises aspecific weight ratio of silicone to methylbenzene. In variousembodiments, said weight ratio of silicone to methylbenzene is in arange of 1:100-25:100. In one embodiment, said weight ratio of siliconeto methylbenzene is 8:100.

In various embodiments, said desired thickness is in a range of0.001-0.010 inches.

The present specification also discloses a method for manufacturing aporous structure for an intragastric device, said porous structurecomprising a top, a bottom, and an interior and having a pre-deploymentshape with a first volume and a post-deployment shape with a secondvolume greater than said first volume, wherein, in said post-deploymentshape, said porous structure includes at least one first openingproximate said top and at least one second opening proximate saidbottom, said method comprising the steps of: heat-setting at least oneflexible metal wire or strip having memory shape properties into saidporous structure having said post-deployment shape; spraying said porousstructure with a vapor deposition of a corrosion-resistant material;allowing corrosion-resistant material present on said porous structureafter said spraying to air dry into a solid state; and, repeating thesteps of spraying said porous structure with said corrosion-resistantmaterial and allowing corrosion resistant-material to air dry until acorrosion-resistant material coating having a desired thickness has beendeposited onto said porous structure.

In various embodiments, when in said post-deployment configuration, aplurality of spaces create in said porous structure each has a diameterof 2-20 mm.

In one embodiment, said corrosion-resistant material comprises parylene.

In various embodiments, said desired thickness is in a range of0.001-0.010 inches.

The present specification also discloses a method for manufacturing aporous structure for an intragastric device, said porous structurecomprising a top, a bottom, and an interior and having a pre-deploymentshape with a first volume and a post-deployment shape with a secondvolume greater than said first volume, wherein, in said post-deploymentshape, said porous structure includes at least one first openingproximate said top and at least one second opening proximate saidbottom, said method comprising the steps of: heat-setting at least oneflexible metal wire or strip having memory shape properties into saidporous structure having said post-deployment shape; dipping the entiretyof said porous structure into a first corrosion-resistant material thathas been heated to a liquid state; removing said porous structure fromsaid first corrosion-resistant material; allowing firstcorrosion-resistant material present on said porous structure after saiddipping and removing to air dry into a solid state; and, repeating thesteps of dipping said porous structure into said firstcorrosion-resistant material, removing said porous structure from saidfirst corrosion-resistant material, and allowing first corrosionresistant-material to air dry, until a first corrosion-resistantmaterial coating having a first desired thickness has been depositedonto said porous structure; spraying said porous structure having saidfirst corrosion-resistant material coating with a vapor deposition of asecond corrosion-resistant material; allowing second corrosion-resistantmaterial present on said porous structure after said spraying to air dryinto a solid state; and, repeating the steps of spraying said porousstructure with said second corrosion-resistant material and allowingsecond corrosion resistant-material to air dry until a secondcorrosion-resistant material coating having a second desired thicknesshas been deposited onto said porous structure.

In various embodiments, when in said post-deployment configuration, aplurality of spaces create in said porous structure each has a diameterof 2-20 mm.

In various embodiments, said first corrosion-resistant materialcomprises a specific weight ratio of silicone to methylbenzene. Invarious embodiments, said weight ratio of silicone to methylbenzene isin a range of 1:100-25:100. In one embodiment, said weight ratio ofsilicone to methylbenzene is 8:100.

In various embodiments, said first desired thickness is in a range of0.001-0.005 inches.

In one embodiment, said second corrosion-resistant material comprisesparylene.

In various embodiments, said second desired thickness is in a range of0.001-0.005 inches.

The present specification also discloses a delivery device forendoscopically delivering an intragastric device into a gastrointestinaltract of a patient, said intragastric device comprising a porousstructure configurable between a compressed pre-deployment configurationand an expanded post-deployment configuration and an elongate sleevecoupled to a distal end of said porous structure, said delivery devicecomprising: an elongate body having a proximal end and a distal end;and, a restraining mechanism for constricting said device in saidpre-deployment configuration coaxially over said distal end of saidelongate body.

In one embodiment, the delivery device further comprises a lockingmechanism for locking said delivery device in a specific position.

In one embodiment, said distal end comprises a most distal portion and aproximal distal portion, wherein said most distal portion is moreflexible than said proximal distal portion.

In one embodiment, the delivery device further comprises a thread pullport on said proximal end, wherein said restraining mechanism comprisesa thread wrapped about said device in said pre-deployment configuration.

In one embodiment, said restraining mechanism comprises a zipped sheathcoaxially covering said device in said pre-deployment configuration. Inanother embodiment, said restraining mechanism comprises a tear awaysheath coaxially covering said device in said pre-deploymentconfiguration.

The present specification also discloses a retrieval device forendoscopically removing an intragastric device from a gastrointestinaltract of a patient, said intragastric device comprising a porousstructure configurable between a compressed pre-deployment configurationand an expanded post-deployment configuration and including at least onecircumferential constricting mechanism positioned about said porousstructure and a retrieval mechanism at its proximal end and, an elongatesleeve coupled to a distal end of said porous structure, said retrievaldevice comprising: an elongate body having a proximal end and a distalend and a lumen within; an elongate metal wire disposed within saidlumen and having a proximal end and a distal end; a grasping mechanismformed from said distal end of said wire for grasping a free end of saidat least one circumferential constricting mechanism and said retrievalmechanism of said porous structure; and, an actuator attached to saidproximal end of said wire.

In one embodiment, the retrieval device further comprises a grasperhaving two opposing jaws attached to said distal end of said elongatebody and operatively connected to said actuator at said proximal end ofsaid wire and at least one clamp positioned between said jaws of saidgrasper.

The present specification also discloses a method of delivering anintragastric device into the gastrointestinal tract of a patient using adelivery device, wherein said intragastric device comprises a porousstructure configurable between a compressed pre-deployment configurationand an expanded post-deployment configuration and an elongate sleevecoupled to a distal end of said porous structure, said method comprisingthe steps of: using said delivery device to position said porousstructure in a stomach of said patient proximate a pylorus and toposition said sleeve extending through said pylorus and into a duodenumor through said pylorus, through said duodenum, and into a jejunum ofsaid patient; deploying said intragastric device such that said porousstructure remains free-floating in said stomach and said sleeve remainsin said patient's small intestine.

In one embodiment, said delivery device comprises an elongate bodyhaving a proximal end, a distal end, a thread pull port on said body,and a thread for wrapping about said intragastric device forconstricting said intragastric device in said pre-deploymentconfiguration coaxially over said distal end of said body of saiddelivery device, and said method further comprises the steps of:coaxially placing said constricted intragastric device in saidpre-deployment configuration over said distal end of said body of saiddelivery device; endoscopically inserting said delivery device into apatient and advancing said distal end of said body of said deliverydevice to a duodenum or jejunum of said patient; once intragastricdevice is positioned, pulling on said thread from said thread pull portto remove said thread from said constricted intragastric device,allowing said intragastric device to automatically expand into saidpost-deployment configuration; and, sliding said distal end of said bodyof said delivery device coaxially away from said expanded intragastricdevice and removing said delivery device from said patient.

In one embodiment, the method further comprises the step of applying acooling element to said compressed intragastric device to slow theexpansion of said porous structure during the removal of said thread,facilitating the removal of said delivery device.

In another embodiment, said delivery device comprises an elongate bodyhaving a proximal end, a distal end, and a zipped sheath for coaxiallysliding over said intragastric device for constricting said intragastricdevice in said pre-deployment configuration coaxially over said distalend of said body of said delivery device, and said method furthercomprises the steps of: coaxially placing said constricted intragastricdevice in said pre-deployment configuration over said distal end of saidbody of said delivery device; endoscopically inserting said deliverydevice into a patient and advancing said distal end of said body of saiddelivery device to a duodenum or jejunum of said patient; onceintragastric device is positioned, using a working tool to unzip saidzipped sheath to remove said sheath from said constricted intragastricdevice, allowing said intragastric device to automatically expand intosaid post-deployment configuration; and, sliding said distal end of saidbody of said delivery device coaxially away from said expandedintragastric device and removing said delivery device from said patient.

In one embodiment, the method further comprises the step of applying acooling element to said compressed intragastric device to slow theexpansion of said porous structure during removal of said sheath,facilitating the removal of said delivery device.

In another embodiment, said delivery device comprises an elongate bodyhaving a proximal end, a distal end, and a tear away sheath forcoaxially sliding over said intragastric device for constricting saidintragastric device in said pre-deployment configuration coaxially oversaid distal end of said body of said delivery device, and said methodfurther comprises the steps of: coaxially placing said constrictedintragastric device in said pre-deployment configuration over saiddistal end of said body of said delivery device; endoscopicallyinserting said delivery device into a patient and advancing said distalend of said body of said delivery device to a duodenum or jejunum ofsaid patient; once intragastric device is positioned, using a workingtool to tear said tear away sheath to remove said sheath from saidconstricted intragastric device, allowing said intragastric device toautomatically expand into said post-deployment configuration; and,sliding said distal end of said body of said delivery device coaxiallyaway from said expanded intragastric device and removing said deliverydevice from said patient.

In one embodiment, the method further comprises the step of applying acooling element to said compressed intragastric device to slow theexpansion of said porous structure during removal of said sheath,facilitating the removal of said delivery device.

The present specification also discloses a method of delivering anintragastric device into the gastrointestinal tract of a patient using adelivery device, wherein said intragastric device comprises a porousstructure configurable between a compressed pre-deployment configurationand an expanded post-deployment configuration and an elongate sleevecoupled to a distal end of said porous structure, said method comprisingthe steps of: deploying said porous structure without said sleeve andallowing said porous structure to expand into said post-deploymentconfiguration in a first procedure; deploying said sleeve within saidexpanded porous structure in a second procedure; and coupling a proximalend of said sleeve to a distal end of said porous structure during saidsecond procedure.

The present specification also discloses a method of retrieving a devicefrom a gastrointestinal tract of a patient using a retrieval device,wherein said device comprises a porous structure configurable between acompressed pre-deployment configuration and an expanded post-deploymentconfiguration and includes at least one circumferential constrictingmechanism positioned about said porous structure and a retrievalmechanism at its proximal end and, an elongate sleeve coupled to adistal end of said porous structure, and said retrieval device comprisesan elongate body having a proximal end and a distal end and a lumenwithin, an elongate metal wire disposed within said lumen and having aproximal end and a distal end, a grasping mechanism formed from saiddistal end of said wire for grasping a free end of said at least onecircumferential constricting mechanism and said retrieval mechanism ofsaid porous structure, and an actuator attached to said proximal end ofsaid wire, said method comprising the steps of: endoscopically insertingsaid retrieval device into said patient and advancing said distal end ofsaid body of said retrieval device to a proximal end of said device;manipulating said grasping mechanism of said retrieval device to engagea free end of said at least one circumferential constricting mechanismpositioned about said porous structure; pulling on said actuator of saidretrieval device to constrict and automatically lock said at least onecircumferential constricting mechanism, thereby compressing said porousstructure into said pre-deployment shape; manipulating said graspingmechanism of said retrieval device to disengage said free end of said atleast one circumferential constricting mechanism; manipulating saidgrasping mechanism to engage said retrieval mechanism at said proximalend of said porous structure; pulling said actuator to withdraw aproximal portion of said device into said lumen of said retrievaldevice; and, removing said retrieval device and said device from saidpatient.

In one embodiment, the method further comprises the step of applying acooling element to said compressed device to prevent the re-expansion ofsaid porous structure during removal of said retrieval device and saiddevice.

The present specification also discloses a method of retrieving a devicefrom a gastrointestinal tract of a patient using a retrieval device,wherein said device comprises a porous structure configurable between acompressed pre-deployment configuration and an expanded post-deploymentconfiguration and includes at least one circumferential constrictingmechanism positioned about said porous structure and, an elongate sleevecoupled to a distal end of said porous structure, and said retrievaldevice comprises an elongate body having a proximal end and a distal endand a lumen within, an elongate metal wire disposed within said lumenand having a proximal end and a distal end, an engaging or graspingmechanism formed from said distal end of said wire for grasping a freeend of said at least one circumferential constricting mechanism, anactuator attached to said proximal end of said wire, a grasper havingtwo opposing jaws attached to said distal end of said elongate body andoperatively connected to said actuator at said proximal end of saidwire, and at least one clamp positioned between said jaws of saidgrasper, said method comprising the steps of: endoscopically insertingsaid retrieval device into said patient and advancing said distal end ofsaid body of said retrieval device to a proximal end of said device;manipulating said grasping mechanism of said retrieval device to engagea free end of said at least one circumferential constricting mechanismpositioned about said porous structure; pulling on said actuator of saidretrieval device to constrict said at least one circumferentialconstricting mechanism, thereby compressing said porous structure intosaid pre-deployment shape; manipulating said grasper of said retrievaldevice to apply said at least one clamp to said free end of said atleast one circumferential constricting mechanism proximate saidcompressed porous structure; pulling said actuator to withdraw aproximal portion of said device into said lumen of said retrievaldevice; and, removing said retrieval device and said device from saidpatient.

In one embodiment, the method further comprises the step of applying acooling element to said compressed device to prevent the re-expansion ofsaid porous structure during removal of said retrieval device and saiddevice.

The present specification also discloses a method of treating acondition of a patient, said method comprising the steps of: deliveringan intragastric device, comprising a porous structure configurablebetween a compressed pre-deployment configuration and an expandedpost-deployment configuration and an elongate sleeve coupled to a distalend of said porous structure, into a gastrointestinal tract of apatient; allowing said porous structure to expand into saidpost-deployment shape; leaving said intragastric device in saidgastrointestinal tract for a sufficient duration to have a therapeuticeffect; constraining said porous structure into said pre-deploymentshape; removing said intragastric device from said gastrointestinaltract of said patient while said device is constrained in saidpre-deployment configuration.

In various embodiments, said condition is any one or combination ofobesity and type II diabetes.

The present specification also discloses a method of treatmentcomprising the steps of: deploying a freely floating device having aproximal and a distal end and comprising a porous structure coupled to aproximal portion of an unsupported flexible sleeve, said device havingopenings at said proximal and distal ends, into a stomach to receivepartially digested food from said stomach; and extending saidunsupported flexible sleeve distally into a small intestine to deliversaid received partially digested food into said small intestine.

The present specification also discloses a method of treatmentcomprising the steps of: deploying a freely floating device with aporous structure into a stomach; coupling a proximal portion of anunsupported sleeve, open at a proximal end and a distal end, to saidporous structure; and extending said unsupported flexible sleevedistally into a small intestine.

The present specification also discloses an intragastric device having atop and a bottom comprising: a structure having a pre-deployment shapewith a first volume and a post-deployment shape with a second volume,wherein said first volume is less than said second volume; wherein, insaid post-deployment shape, said device comprises at least one firstopening proximate to the top of said device, each first opening definedby an area where a sum of the areas of the first openings is equal to afirst area; wherein, in said post-deployment shape, said devicecomprises at least one second opening proximate to the bottom of saiddevice, each second opening defined by an area where a sum of the areasof the second openings is equal to a second area; and wherein said firstarea is equal or larger than said second area. Optionally, thepre-deployment shape is linear, cylindrical, conical, a non-linearcylinder, spherical, a cube or a cuboid. Optionally, the structurecomprises at least one of a mesh structure, a spiral structure, or alattice structure. The device on deployment spontaneously assumes thepost-deployment shape and volume without the need of fillers.Alternatively, a balloon could be used to assist the transition from thepre-deployment shape to the post-deployment shape but following that thedevice maintains the post-deployment shape and volume without the needof fillers.

Optionally, the wire mesh has a plurality of vertical and horizontalelements which, when expanded, create the at least one first opening andthe at least one second opening. The wire mesh vertical and horizontalelements comprise at least one of a metal, an alloy, a polymer, a shapememory metal, or a shape memory polymer. The structure is enveloped by apartially perforated membrane having a surface area. The membranecomprises at least one of silicone, latex, parylene, polyurethane,polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene(ePTFE), fluorinated ethylene-propylene, Dacron, or Polyethyleneterephthalate (PET). The membrane has at least one first membraneopening, each first membrane opening having a first membrane openingarea where a sum of said first membrane opening areas is equal to athird area, wherein said at least one first membrane opening isproximate to the top of the device.

The membrane has at least one second membrane opening, each secondmembrane opening having a second membrane opening area where a sum ofsaid second membrane opening areas is equal to a fourth area, whereinsaid at least one second membrane opening is proximate to the bottom ofthe device and wherein the third area is equal or larger than the fourtharea. The sum of said third area and fourth area is between one andninety-nine percent of the membrane surface area. The membrane comprisesat least one opening wherein said opening has at least one valve thatcontrols a directionality of flow of food or nutrients in and out of thedevice.

Optionally, the device is attached to a catheter, wherein said catheteris configured to induce a change from the pre-deployment shape to saidpost-deployment shape. A sleeve is attached to the bottom of saiddevice, wherein said sleeve has a length sufficient to extend from thebottom of the device, through a patient's pylorus and duodenum, and intothe patient's jejunum. The sleeve comprises at least one of silicone,latex, parylene, polyurethane, polytetrafluoroethylene (PTFE), expandedpolytetrafluoroethylene (ePTFE), fluorinated ethylene-propylene, Dacron,or Polyethylene terephthalate (PET). Optionally, in one embodiment, thedevice is configured to receive a second intragastric device.

In another embodiment, the present specification discloses anintragastric device having a top and a bottom comprising: a structurehaving a pre-deployment shape with a first volume and a post-deploymentshape with a second volume, wherein said first volume is less than saidsecond volume; wherein, in said post-deployment shape, said devicecomprises a plurality of first openings, each of said plurality of firstopenings defined by an area where a sum of the areas of the plurality offirst openings is equal to a first area; wherein, in saidpost-deployment shape, said device comprises a plurality of secondopenings, each of said plurality of second openings defined by an areawhere a sum of the areas of the plurality of second openings is equal toa second area; wherein said first area is equal to larger than saidsecond area; wherein said first area is closer to the top of devicerelative to the second area; and wherein said structure is enveloped bya membrane that does not cover said first area or said second area.

In another embodiment, the present specification discloses anintragastric device having a top and a bottom comprising: a structurehaving a pre-deployment shape with a first volume and a post-deploymentshape with a second volume, wherein said first volume is less than saidsecond volume; wherein, in said post-deployment shape, said devicecomprises at least one first opening to allow for entry of food into thedevice and at least one second opening to allow for exit of food fromthe device, wherein the device has a first weight when a patient is in apre-feeding stage and a second weight when a patient is in a feeding ora post-feeding stage, and wherein the second weight is greater than thefirst weight. A patient is in a feeding stage when a patient is activelyingesting food or nutrients. This stage typically lasts between 1 minuteand 1 hour. A patient is in a post-feeding stage after the patient hasstopped ingesting food or nutrients and until most of the food ornutrients have exited the stomach. This stage normally lasts between 15minutes and 4 hours and depends upon the amount and type of food ornutrients ingested. This state is also affected by the health of patientand can be significantly prolonged in patients having gastric emptyingabnormalities such as gastroparesis. A patient is in a pre-feeding stagebetween the end of the post-feeding stage and the beginning of thefeeding stage. In one embodiment, the first opening is the same as thesecond opening. In other embodiments, the first opening is differentfrom the second opening. In various embodiments, the device has a tophalf with a first weight and a bottom half with a second weight whereinthe first weight is different from the second weight.

The present specification also discloses an intragastric devicecomprising: a structure having a pre-deployment shape with a firstvolume and a post-deployment shape with a second volume, wherein saidfirst volume is less than said second volume, further wherein, when insaid post-deployment shape, said structure approximates a lowerhemisphere shape, said structure having a top and a bottom, said topcomprising a first opening and said bottom comprising a second openingwherein said first opening is larger than said second opening; anelongate tubular member having a proximal end, a distal end, and a lumenwithin, said tubular member further comprising a third opening at itsproximal end and a fourth opening proximate its distal end, saidproximal end of said tubular member attached to said bottom of saidstructure; and wherein, when said device is rotated about a horizontalaxis, contents within said structure that are too large to pass throughsaid second opening exit said structure via said first opening.

The present specification also discloses an intragastric device having atop and a bottom comprising: a structure having a pre-deployment shapewith a first volume and a post-deployment shape with a second volume,wherein said first volume is less than said second volume; wherein, insaid post-deployment shape, said device comprises at least one firstopening proximate to the top of said device, further wherein said top ofsaid device has a first radial force; wherein, in said post-deploymentshape, said device comprises at least one second opening proximate tothe bottom of said device, further wherein said bottom of said devicehas a second radial force; and wherein said first radial force isgreater than said second radial force.

The present specification also discloses an intragastric device having atop and a bottom comprising: a structure having a pre-deployment shapewith a first volume and a post-deployment shape with a second volume,wherein said first volume is less than said second volume; wherein, insaid post-deployment shape, said device comprises at least one firstopening proximate to the top of said device, further wherein said top ofsaid device comprises a wire structure having a radial force; andwherein, in said post-deployment shape, said device comprises at leastone second opening proximate to the bottom of said device, furtherwherein said bottom of said device comprises a compressible membranousmember.

The present specification also discloses an intragastric device for usefollowing bariatric surgery, comprising: a structure having apre-deployment shape with a first volume and a post-deployment shapewith a second volume, wherein said first volume is less than said secondvolume, further wherein said structure approximates a sphere, ovoid, oranatomy conforming shape when in said post-deployment shape, saidstructure having a proximal end and a distal end, said proximal endhaving one or more openings and said distal end having one opening; anelongate tubular member having a proximal end, a distal end, and a lumenwithin, wherein said proximal end of said tubular member is attached toand partially covers said distal end of said structure, further whereinsaid lumen of said tubular member is in fluid communication with saidopening at said distal end of said structure; and wherein said structureand said tubular member are configured to be positioned within a gastricremnant and small intestine of a patient following bariatric surgery.

In one embodiment, the intragastric device further comprises at leastone valve at said one or more openings at said proximal end of saidstructure.

In one embodiment, the intragastric device further comprises at leastone anchoring mechanism for anchoring said device followingimplantation.

In one embodiment, the intragastric device further comprises at leastone weighting mechanism proximate said distal end of said tubularmember.

In one embodiment, the intragastric device has a wire mesh collarattached to one of its ends, said collar having a pre-deployment shapewith a first volume and a post-deployment shape with a second volume,wherein said first volume is less than said second volume, furtherwherein said structure approximates a disc, donut, sphere, ovoid, oranatomy conforming shape when in said post-deployment shape. The collarserves an anti-migration function, preventing the migration of thedevice out of the stomach. Alternatively, the collar may serve topreferentially add weight to one of the end of the device.

In one embodiment, the distal end of the tubular member extends furtherdistally beyond the distal opening.

In one embodiment, the intragastric device further comprises at leastone constricting mechanism for returning said device to saidpre-deployment shape.

The present specification also discloses an intragastric device for usefollowing bariatric surgery, comprising: a structure having apre-deployment shape with a first volume and a post-deployment shapewith a second volume, wherein said first volume is less than said secondvolume, said structure having a proximal end and a distal end, saidproximal end having one or more openings and said distal end having oneopening, wherein a first diameter of said proximal end of said structureis less than a second diameter of said distal end of said structure whenin said post-deployment shape; an elongate tubular member having aproximal end, a distal end, and a lumen within, wherein said proximalend of said tubular member is attached to and partially covers saiddistal end of said structure, further wherein said lumen of said tubularmember is in fluid communication with said opening at said distal end ofsaid structure; and wherein said structure and said tubular member areconfigured to be positioned within a gastric remnant and small intestineof a patient following bariatric surgery.

In one embodiment, the intragastric device further comprises at leastone valve at said one or more openings at said proximal end of saidstructure.

In one embodiment, the intragastric device further comprises at leastone valve at said one or more openings at said distal end of saidstructure.

In one embodiment, the intragastric device further comprises at leastone anchoring mechanism for anchoring said device followingimplantation.

In one embodiment, the intragastric device further comprises at leastone weighting mechanism proximate said distal end of said tubularmember.

In one embodiment, the distal end of the tubular member extends furtherdistally beyond the distal opening.

In one embodiment, the intragastric device further comprises at leastone constricting mechanism for returning said device to saidpre-deployment shape.

The present specification also discloses an intragastric device for usefollowing bariatric surgery, comprising: a structure having apre-deployment shape with a first volume and a post-deployment shapewith a second volume, wherein said first volume is less than said secondvolume, further wherein said structure approximates a sphere, ovoid, oranatomy conforming shape when in said post-deployment shape, saidstructure having a proximal end and a distal end, said proximal endhaving one or more openings and said distal end having one opening; anelongate tubular member having a proximal end, a distal end, and a lumenwithin, wherein said proximal end of said tubular member is attached toand partially covers said distal end of said structure, further whereinsaid lumen of said tubular member is in fluid communication with saidopening at said distal end of said structure; and wherein said structureand said tubular member are configured to be positioned within a gastricpouch and jejunum of a patient following bariatric surgery.

In one embodiment, the intragastric device further comprises at leastone valve at said one or more openings at said proximal end of saidstructure.

In one embodiment, the valve at said one or more openings at saidproximal end of said structure is a flap valve or a tubular membranevalve.

In one embodiment, the intragastric device further comprises at leastone anchoring mechanism for anchoring said device followingimplantation.

In one embodiment, the intragastric device further comprises at leastone weighting mechanism proximate said distal end of said tubularmember.

In one embodiment, the distal end of the tubular member extends furtherdistally beyond the distal opening.

In one embodiment, the intragastric device further comprises at leastone constricting mechanism for returning said device to saidpre-deployment shape.

The present specification also discloses a method for retrieving animplanted intragastric device, said method comprising the steps of:inserting an endoscope into the esophagus of a patient having anintragastric device implanted, said device comprising a proximal end, adistal end, and at least one constricting mechanism for converting saiddevice from a post-deployment configuration to approximate apre-deployment configuration, wherein said pre-deployment configurationapproximates an elongate slender cylinder having a diameter smaller thanthat of a gastric overtube (<20 mm); advancing a grasping device througha working channel of an endoscope; grasping a portion of each of said atleast one constricting mechanism; pulling on said portion to tightensaid constricting mechanism, thereby causing said device to returnsubstantially to said pre-deployment configuration; grasping saidproximal end of said device; and, pulling on said device to remove itfrom said patient through said overtube or an endoscope.

The present specification also discloses an intragastric device having awire mesh structure wherein said wire mesh structure comprises: athree-dimensional structure having a proximal end, a distal end, and avolume defined within; a compressed pre-deployment configuration and anexpanded post-deployment configuration wherein the volume of saidpost-deployment configuration is greater than the volume of saidpre-deployment configuration; and, at least one first opening proximatethe proximal end of said wire mesh structure and at least one secondopening proximate the distal end of said wire mesh structure whereinsaid at least one second opening is larger than said at least one firstopening. The device on deployment spontaneously transitions from thepre-deployment configuration to the post-deployment configuration.Alternatively, an inflatable balloon could be used to create thepost-deployment configuration. The device then maintains thepost-deployment configuration without the need for a balloon or fillers.

In one embodiment, when in said post-deployment configuration, saiddevice occupies at least 10% of a patient's stomach volume. In oneembodiment, when in said post-deployment configuration, the wires ofsaid wire mesh structure comprise 50% or less of the surface area ofsaid wire mesh structure and openings between said wires comprise theremaining surface area. In one embodiment, when in said post-deploymentconfiguration, the diameter of said device is greater than the diameterof an open pylorus. In one embodiment, when in said post-deploymentconfiguration, said device is capable of moving no more than 15 inchesproximally and distally within a patient's stomach. In one embodiment,the device freely floats inside the stomach and any portion of thedevice is free to move relative to any portion of the gastrointestinaltract.

In one embodiment, when in said pre-deployment configuration, saiddevice has a shape comprising any one of linear, cylindrical, orconical. In one embodiment, when in said pre-deployment configuration,said device has a diameter or 25 mm or less.

In one embodiment, when in said post-deployment configuration, saiddevice has a shape comprising any one of spherical, oval, ovoid, bean,stomach shaped, or football shaped. In various embodiments, when in saidpost-deployment configuration, said device has a width within a range of1 cm to 25 cm and a length within a range of 1 cm to 25 cm.

In one embodiment, when in said post-deployment configuration, the wiremesh structure has a length from its proximal end to its distal end thatis greater than a width of the wire mesh structure that extends, at themidpoint between said proximal end and said distal end, from one side ofsaid wire mesh structure to the opposite side of said wire meshstructure. In another embodiment, when in said post-deploymentconfiguration, the wire mesh structure has a length from its proximalend to its distal end that is equal to a width of the wire meshstructure that extends, at the midpoint between said proximal end andsaid distal end, from one side of said wire mesh structure to theopposite side of said wire mesh structure. In another embodiment, whenin said post-deployment configuration, the wire mesh structure has alength from its proximal end to its distal end that is less than a widthof the wire mesh structure that extends, at the midpoint between saidproximal end and said distal end, from one side of said wire meshstructure to the opposite side of said wire mesh structure.

In one embodiment, said wire mesh structure is comprised of metal. Inone embodiment, said metal is coated with a corrosive resistantmaterial. In one embodiment, said corrosive resistant material comprisesany one of silicone, polyester, polyether ether ketone (PEEK), a medicalgrade epoxy, ceramic, or an additional metal. In one embodiment, thecoating metal is tantalum. Tantalum provides corrosive resistance andradiopacity. In one embodiment, wherein the coating is ceramic, theceramic coating has a thickness of several angstroms. In variousembodiments, any one or combination of the above corrosive resistantmaterials is used to coat the metal of the wire mesh structure.

In one embodiment, said metal of said wire mesh structure is a shapememory metal. In one embodiment, said shape memory metal is Nitinol. Inone embodiment, said shape memory metal is temperature sensitive.

In one embodiment, said wire mesh structure is comprised of a polymer.In one embodiment, said polymer is polyether ether ketone (PEEK) or abioresorbable polymer. In another embodiment, said wire mesh structureis made of carbon fibers.

In one embodiment, said at least one first opening has a diameter of 50mm or less. In one embodiment, said at least one second opening has adiameter of 4 inches or less.

In one embodiment, when in said post-deployment configuration, said wiremesh structure comprises a wire mesh weave pattern which makes the wiremesh structure more easily compressible along the vertical axis. Inanother embodiment, when in said post-deployment configuration, saidwire mesh structure comprises a wire mesh weave pattern which makes thewire mesh structure more easily compressible along the horizontal axis.

In one embodiment, when in said post-deployment configuration, said wiremesh structure comprises a wire mesh weave pattern which provides aconsistent radial strength throughout said wire mesh structure, whereinsaid radial strength is greater than the compressive force of apatient's stomach.

In one embodiment, when in said post-deployment configuration, said wiremesh structure comprises an upper portion extending from said proximalend to a middle point halfway between said proximal end and said distalend and a lower portion extending from said distal end to a middle pointhalfway between said proximal end and said distal end. In oneembodiment, said upper portion comprises a first wire mesh weave patternwhich provides said upper portion with a radial strength greater thanthe radial strength provided to the lower portion by a second wire meshweave pattern of said lower portion. In another embodiment, said upperportion comprises a wire mesh weave pattern which provides said upperportion with a radial strength greater than the compressive force of apatient's stomach and said lower portion comprises a flexible,compressible membrane.

In one embodiment, said wire mesh structure further comprises amechanism which is designed to be manually engaged when said device isin said post-deployment configuration wherein said mechanism providessaid wire mesh structure with a radial strength greater than thecompressive force of a patient's stomach. In one embodiment, saidmechanism comprises any one of a rod, spoke, disc, or separate devicedeployed within said wire mesh structure.

In one embodiment, the intragastric device further comprises a membranecovering a portion of said wire mesh structure, wherein said portioncomprises 1% to 100% of the surface area of said wire mesh structurewhich excludes said first and second openings. In one embodiment, saidmembrane is substantially non-porous. In another embodiment, saidmembrane has a specific level of porosity. In one embodiment, saidmembrane comprises at least one opening wherein said at least oneopening is positioned to align with at least one opening between thewires of said wire mesh structure. In one embodiment, said membraneincludes a unidirectional valve or flap at said at least one opening insaid membrane to allow the passage of food into but not out of saiddevice.

In one embodiment, the intragastric device further comprises at leastone circumferential constricting mechanism positioned about said wiremesh structure.

In one embodiment, said wire mesh structure further includes aradiopaque marker to facilitate delivery using radiographicvisualization.

In one embodiment, the intragastric device further comprises at leastone sensor. In one embodiment, said sensor comprises any one orcombination of a flow or impedance sensor, a glucose sensor, atemperature sensor, a pH sensor and an accelerometer.

In one embodiment, the intragastric device further comprises a sleevecoupled to a distal portion of said wire mesh structure, wherein saidsleeve comprises: a flexible elongate body having a proximal end, adistal end, and a lumen within; a first opening at said proximal end;and, a second opening proximate said distal end.

In one embodiment, said proximal end of said sleeve is positioned in theantrum of a patient's stomach, said body of said sleeve extends througha pylorus of a patient and into a patient's duodenum, and said secondopening of said sleeve opens into said duodenum. In another embodiment,said proximal end of said sleeve is positioned in the antrum of apatient's stomach, said body of said sleeve extends through a pylorusand duodenum of a patient and into a patient's jejunum, and said secondopening of said sleeve opens into said jejunum.

In one embodiment, said second opening of said sleeve is positioned onsaid elongate body proximal to said distal end and said sleeve furthercomprises a pouch at said distal end. In another embodiment, said secondopening of said sleeve is positioned at said distal end of sleeve.

In various embodiments, said sleeve has a length within a range of 6inches to 120 inches. In one embodiment, said sleeve has a length of 24inches. In another embodiment, said sleeve has a length of 30 inches.

In various embodiments, said sleeve has a diameter within a range of 1cm to 10 cm. In one embodiment, said sleeve has a diameter of 3 cm.

In one embodiment, said distal end of sleeve is weighted to maintainsleeve in an elongate shape.

In one embodiment, said sleeve is coupled to said wire mesh structurevia sutures. In another embodiment, said device further includes a wiremesh adapter coupling said sleeve with said wire mesh structure. Inanother embodiment, said sleeve is coupled via at least two couplingmechanisms to said wire mesh structure at a distance distally away fromsaid wire mesh structure.

In one embodiment, the intragastric device further comprises a secondsleeve wherein said second sleeve comprises a flexible elongate bodyhaving a proximal end, a distal end, and a lumen within, a first openingat said proximal end, and a second opening proximate said distal endwherein said first opening of said second sleeve and a diameter of saidsecond sleeve are the same size or greater in size than a diameter ofsaid first sleeve, further wherein said first sleeve is coupled directlyto said wire mesh structure and said second sleeve is coupled via atleast two coupling mechanisms to said wire mesh structure at a distancedistally away from said wire mesh structure, still further wherein saiddistal end of said first sleeve extends through said first opening ofsaid second sleeve such that said second opening of said first sleeveopens into said lumen of said second sleeve. Alternatively, the secondsleeve is attached directly to the first sleeve at one or more points.

In one embodiment, said sleeve is comprised of a corrosive resistantmaterial.

-   -   In one embodiment, said sleeve is comprised of a biocompatible        material.

In one embodiment, said sleeve comprises a flexible coil or mesh havinga weave pattern which provides the sleeve with anti-torsional propertiesand structural support such that said sleeve remains in an elongateshape. In another embodiment, said sleeve comprises a membrane having aplurality of horizontal and vertical support elements which provide thesleeve with anti-torsional properties and structural support such thatsaid sleeve remains in an elongate shape. In various embodiments, saidhorizontal support elements are spaced between 1 inch and 24 inchesapart from one another and said vertical support elements are between 1inch and 60 inches in length. In one embodiment, said horizontal supportelements are spaced 6 inches apart from one another and said verticalsupport elements are 6 inches in length. In another embodiment, saidsleeve comprises a membrane having a spiral metal wire extending itsentire length which provides the sleeve with anti-torsional propertiesand structural support such that said sleeve remains in an elongateshape.

In one embodiment, said sleeve is capable of telescoping into itself. Inthe embodiment with two or more sleeves, the distal sleeve(s) telescopesinto or over the proximal sleeve(s).

In one embodiment, said sleeve comprises a membrane and said membrane ofsaid sleeve extends onto a portion of said wire mesh structure.

In one embodiment, said sleeve further comprises a radiopaque marker tofacilitate delivery using radiographic visualization.

In one embodiment, the intragastric device further comprises a retrievalmechanism fixedly attached to the proximal end of said wire meshstructure. In one embodiment, said retrieval mechanism comprises aretrieval suture having a loop shape.

In one embodiment, the intragastric device further comprises ananti-migration component attached to the distal end of said wire meshstructure, wherein said anti-migration component comprises a compressedpre-deployment configuration and an expanded post-deploymentconfiguration and is designed to sit proximal to a patient's pylorus andprevent migration of the wire mesh structure into and through saidpylorus.

In one embodiment, when in said pre-deployment configuration, saidanti-migration component has a shape comprising any one of linear,cylindrical, or conical.

In one embodiment, when in said post-deployment configuration, saidanti-migration component has a shape comprising any one of discoidsloping proximally, discoid sloping proximally, flat discoid orcircular, a half bumper, a full bumper, a flower shape, a donut shape ora saucer shape. In another embodiment, the anti-migration collar isspherical in shape. In another embodiment, the weave of theanti-migration collar is different than the weave of the mesh to provideit with different compressibility than the mesh.

In one embodiment, when in said post-deployment configuration, saidanti-migration component has a width that is greater than the diameterof the wire mesh structure.

In another embodiment, when in said post-deployment configuration, saidanti-migration component has a width that is less than the diameter ofthe wire mesh structure.

In another embodiment, when in said post-deployment configuration, saidanti-migration component has a width that is similar to the diameter ofthe wire mesh structure.

In one embodiment, when in said post-deployment configuration, saidanti-migration component has a radial strength that is greater than thecompressive force of a patient's stomach.

In one embodiment, said anti-migration component is comprised of metal.In one embodiment, said metal is a shape memory metal. In oneembodiment, said shape memory metal is Nitinol. In one embodiment, saidmetal is temperature sensitive. In one embodiment, said anti-migrationcomponent is coated with a corrosive resistant material. In oneembodiment, said corrosive resistant material is silicone, polyester,polyether ether ketone (PEEK), parylene, a medical grade epoxy, ceramic,or an additional metal. In one embodiment, the coating metal istantalum. Tantalum provides corrosive resistance and radiopacity. In oneembodiment, wherein the coating is ceramic, the ceramic coating has athickness of several angstroms. In various embodiments, any one orcombination of the above corrosive resistant materials is used to coatthe metal of the wire mesh structure. In one embodiment, saidanti-migration component further includes a radiographic marker tofacilitate delivery using radiographic visualization.

In one embodiment, the intragastric device further comprises a secondwire mesh structure having a proximal end and a distal end and a volumewithin, wherein said proximal end of said second wire mesh structure isremovably attached to said distal end of said first wire mesh structure,further wherein said second wire mesh structure is also configurablebetween a compressed pre-deployment configuration and a post-deploymentconfiguration. In one embodiment, the intragastric device having firstand second wire mesh structures further comprises a first anti-migrationcomponent attached to the distal end of said first wire mesh structureand extending into the volume of said second wire mesh structure and asecond anti-migration component attached to the distal end of saidsecond wire mesh structure, wherein said first wire mesh structurefunctions to couple said first wire mesh structure and said second wiremesh together and maintain the expanded configuration of said secondwire mesh structure and said second anti-migration component functionsto prevent said device from being passed into and through a patient'spylorus. In one embodiment, the intragastric device having first andsecond wire mesh structures further comprises a sleeve coupled to thedistal end of said second wire mesh structure.

The present specification also discloses a delivery device forendoscopically delivering an intragastric device into a gastrointestinaltract of a patient, said intragastric device comprising a wire meshstructure configurable between a compressed pre-deployment configurationand an expanded post-deployment configuration and an elongate sleevecoupled to a distal end of said wire mesh structure, said deliverydevice comprising: an elongate body having a proximal end and a distalend; and, a restraining mechanism for constricting said device in saidpre-deployment configuration coaxially over said distal end of saidelongate body.

In one embodiment, the delivery device further comprises a lockingmechanism for locking said delivery device in a specific position. Inone embodiment, said distal end of said delivery device comprises a mostdistal portion and a proximal distal portion, wherein said most distalportion is more flexible than said proximal distal portion. In oneembodiment, the delivery device has a lumen for passage over aguidewire. In one embodiment, the most distal portion has a sphericalshape to end to help track the catheter over a guidewire.

In one embodiment, the delivery device further comprises a thread pullport on said proximal end, wherein said restraining mechanism comprisesa thread wrapped about said device in said pre-deployment configuration.In another embodiment, said restraining mechanism comprises a zippedsheath coaxially covering said device in said pre-deploymentconfiguration. In another embodiment, said restraining mechanismcomprises a tear away sheath coaxially covering said device in saidpre-deployment configuration.

The present specification also discloses a retrieval device forendoscopically removing an intragastric device from a gastrointestinaltract of a patient, said intragastric device comprising a wire meshstructure configurable between a compressed pre-deployment configurationand an expanded post-deployment configuration and including at least onecircumferential constricting mechanism positioned about said wire meshstructure and a retrieval mechanism at its proximal end and, an elongatesleeve coupled to a distal end of said wire mesh structure, saidretrieval device comprising: an elongate body having a proximal end anda distal end and a lumen within; an elongate metal wire disposed withinsaid lumen and having a proximal end and a distal end; a grasping orhooking mechanism formed from said distal end of said wire for graspingor hooking a free end of said at least one circumferential constrictingmechanism and said retrieval mechanism of said wire mesh structure; and,an optional actuator attached to said proximal end of said wire.

In one embodiment, the retrieval device further comprises a grasperhaving two opposing jaws attached to said distal end of said elongatebody and operatively connected to said actuator at said proximal end ofsaid wire and at least one clamp positioned between said jaws of saidgrasper.

The present specification also discloses a method of delivering anintragastric device into the gastrointestinal tract of a patient using adelivery device, wherein said intragastric device comprises a wire meshstructure configurable between a compressed pre-deployment configurationand an expanded post-deployment configuration and an elongate sleevecoupled to a distal end of said wire mesh structure, and said deliverydevice comprises an elongate body having a proximal end, a distal end, athread pull port on said body, and a thread for wrapping about saidintragastric device for constricting said intragastric device in saidpre-deployment configuration coaxially over said distal end of said bodyof said delivery device, said method comprising the steps of: coaxiallyplacing said constricted intragastric device in said pre-deploymentconfiguration over said distal end of said body of said delivery device;endoscopically inserting said delivery device into a patient andadvancing said distal end of said body of said delivery device to aduodenum and/or jejunum of said patient; positioning said body of saiddelivery device in said intragastric tract of said patient such thatsaid wire mesh structure is positioned in a stomach of said patientproximate a pylorus and said sleeve is positioned extending through saidpylorus and into said duodenum and/or jejunum; pulling on said threadfrom said thread pull port to remove said thread from said constrictedintragastric device, allowing said intragastric device to automaticallyexpand into said post-deployment configuration; and, sliding said distalend of said body of said delivery device coaxially away from saidexpanded intragastric device and removing said delivery device from saidpatient.

The present specification also discloses a method of delivering anintragastric device into the gastrointestinal tract of a patient using adelivery device, wherein said intragastric device comprises a wire meshstructure configurable between a compressed pre-deployment configurationand an expanded post-deployment configuration and an elongate sleevecoupled to a distal end of said wire mesh structure, and said deliverydevice comprises an elongate body having a proximal end, a distal end,and a zipped sheath for coaxially sliding over said intragastric devicefor constricting said intragastric device in said pre-deploymentconfiguration coaxially over said distal end of said body of saiddelivery device, said method comprising the steps of: coaxially placingsaid constricted intragastric device in said pre-deploymentconfiguration over said distal end of said body of said delivery device;endoscopically inserting said delivery device into a patient andadvancing said distal end of said body of said delivery device to aduodenum and/or jejunum of said patient; positioning said body of saiddelivery device in said gastrointestinal tract of said patient such thatsaid wire mesh structure is positioned in a stomach of said patientproximate a pylorus and said sleeve is positioned extending through saidpylorus and into said duodenum; using a working tool to unzip saidzipped sheath to remove said sheath from said constricted intragastricdevice, allowing said intragastric device to automatically expand intosaid post-deployment configuration; and, sliding said distal end of saidbody of said delivery device coaxially away from said expandedintragastric device and removing said delivery device from said patient.

The present specification also discloses a method of delivering anintragastric device into the gastrointestinal tract of a patient using adelivery device, wherein said intragastric device comprises a wire meshstructure configurable between a compressed pre-deployment configurationand an expanded post-deployment configuration and an elongate sleevecoupled to a distal end of said wire mesh structure, and said deliverydevice comprises an elongate body having a proximal end, a distal end,and a standard sheath or a tear away sheath for coaxially sliding oversaid intragastric device for constricting said intragastric device insaid pre-deployment configuration coaxially over said distal end of saidbody of said delivery device, said method comprising the steps of:coaxially placing said constricted intragastric device in saidpre-deployment configuration over said distal end of said body of saiddelivery device; endoscopically inserting said delivery device with orwithout a guidewire into a patient and advancing said distal end of saidbody of said delivery device to a duodenum and/or jejunum of saidpatient; positioning said body of said delivery device in saidgastrointestinal tract of said patient such that said wire meshstructure is positioned in a stomach of said patient proximate a pylorusand said sleeve is positioned extending through said pylorus and intosaid duodenum; using a working tool to tear said tear away sheath toremove said sheath from said constricted intragastric device, allowingsaid intragastric device to automatically expand into saidpost-deployment configuration; and, sliding said distal end of said bodyof said delivery device coaxially away from said expanded intragastricdevice and removing said delivery device from said patient such that theintragastric device freely moves in the gastric lumen and the sleevefreely moves inside the proximal gastrointestinal tract.

In various embodiments, the intragastric mesh occupies the gastric lumenand moves about freely in the gastric lumen, reducing the volumeavailable for ingested food material. Partially digested food passesinto the mesh, exits the mesh through one or more of its distal ports,enters into the sleeve, and bypasses a proximal portion of the smallintestine. In one embodiment, the intragastric mesh structure canintermittently, with gastric peristalsis, block the passage of food fromthe stomach into the small intestine, thereby delaying gastric emptying.In another embodiment, the intragastric mesh slows the emptying of foodthat has entered the mesh into the small intestine, further delayinggastric emptying.

In one embodiment, the sleeve is made of more than one telescopingsleeves with the most proximal sleeve receiving food from the mesh andemptying into the distal sleeve, while the distal sleeve collects thefood that has passed around the mesh into the small intestine andprevents such bypassed food from coming into contact with a part of thegastrointestinal tract.

In various embodiments, any of the delivery methods above furthercomprises the step of applying a cooling element to said compressedintragastric device to slow the expansion of said wire mesh structureduring removal of said thread or sheath, facilitating the removal ofsaid delivery device.

The present specification also discloses a method of retrieving anintragastric device from a gastrointestinal tract of a patient using aretrieval device, wherein said intragastric device comprises a wire meshstructure configurable between a compressed pre-deployment configurationand an expanded post-deployment configuration and includes at least onecircumferential constricting mechanism positioned about said wire meshstructure and a retrieval mechanism at its proximal end and, an elongatesleeve coupled to a distal end of said wire mesh structure, and saidretrieval device comprises an elongate body having a proximal end and adistal end and a lumen within, an elongate metal wire disposed withinsaid lumen and having a proximal end and a distal end, an engaging orgrasping mechanism formed from said distal end of said wire for engagingor grasping a free end of said at least one circumferential constrictingmechanism and said retrieval mechanism of said wire mesh structure, andan actuator attached to said proximal end of said wire, said methodcomprising the steps of: endoscopically inserting said retrieval deviceinto said patient and advancing said distal end of said body of saidretrieval device to a proximal end of said intragastric device;manipulating said engaging or grasping mechanism of said retrievaldevice to engage a free end of said at least one circumferentialconstricting mechanism positioned about said wire mesh structure;pulling on said actuator of said retrieval device to constrict andautomatically lock said at least one circumferential constrictingmechanism, thereby compressing said wire mesh structure into saidpre-deployment shape; manipulating said grasping mechanism of saidretrieval device to disengage said free end of said at least onecircumferential constricting mechanism; manipulating said graspingmechanism to engage said retrieval mechanism at said proximal end ofsaid wire mesh structure; pulling said actuator to withdraw a proximalportion of said intragastric device into said lumen of said retrievaldevice; and, removing said retrieval device and said intragastric devicefrom said patient.

The present specification also discloses a method of retrieving anintragastric device from a gastrointestinal tract of a patient using aretrieval device, wherein said intragastric device comprises a wire meshstructure configurable between a compressed pre-deployment configurationand an expanded post-deployment configuration and includes at least onecircumferential constricting mechanism positioned about said wire meshstructure and, an elongate sleeve coupled to a distal end of said wiremesh structure, and said retrieval device comprises an elongate bodyhaving a proximal end and a distal end and a lumen within, an elongatemetal wire disposed within said lumen and having a proximal end and adistal end, a grasping mechanism formed from said distal end of saidwire for grasping a free end of said at least one circumferentialconstricting mechanism, an actuator attached to said proximal end ofsaid wire, a grasper having two opposing jaws attached to said distalend of said elongate body and operatively connected to said actuator atsaid proximal end of said wire, and at least one clamp positionedbetween said jaws of said grasper, said method comprising the steps of:endoscopically inserting said retrieval device into said patient andadvancing said distal end of said body of said retrieval device to aproximal end of said intragastric device; manipulating said graspingmechanism of said retrieval device to engage a free end of said at leastone circumferential constricting mechanism positioned about said wiremesh structure; pulling on said actuator of said retrieval device toconstrict said at least one circumferential constricting mechanism,thereby compressing said wire mesh structure into said pre-deploymentshape; manipulating said grasper of said retrieval device to apply saidat least one clamp to said free end of said at least one circumferentialconstricting mechanism proximate said compressed wire mesh structure;pulling said actuator to withdraw a proximal portion of saidintragastric device into said lumen of said retrieval device; and,removing said retrieval device and said intragastric device from saidpatient.

In various embodiments, any of the retrieval methods above furthercomprises the step of applying a cooling element to said compressedintragastric device to prevent the re-expansion of said wire meshstructure during removal of said retrieval device and said intragastricdevice.

The aforementioned and other embodiments of the present invention shallbe described in greater depth in the drawings and detailed descriptionprovided below.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present invention will beappreciated as they become better understood by reference to thefollowing detailed description when considered in connection with theaccompanying drawings, wherein:

FIG. 1 is an illustration of an upper gastrointestinal system;

FIG. 2A is an illustration of a wire mesh structure of an intragastricdevice in a post-deployment configuration in accordance with oneembodiment of the present specification, depicting a first weavepattern;

FIG. 2B is an illustration of a wire mesh structure of an intragastricdevice in a post-deployment configuration in accordance with anotherembodiment of the present specification, depicting a second weavepattern;

FIG. 2C is an illustration of a wire mesh structure of an intragastricdevice in a post-deployment configuration in accordance with anotherembodiment of the present specification, depicting a third weavepattern;

FIG. 2D is an illustration of a wire mesh structure of an intragastricdevice in a post-deployment configuration in accordance with anotherembodiment of the present specification, depicting a fourth weavepattern;

FIG. 2E is an illustration of a wire mesh structure of an intragastricdevice in a post-deployment configuration in accordance with yet anotherembodiment of the present specification, depicting a fifth weavepattern;

FIG. 2F is an illustration of another embodiment of an intragastricdevice in an exemplary post-deployment configuration;

FIG. 2G is an illustration of yet another embodiment of an intragastricdevice in an exemplary post-deployment configuration;

FIG. 2H is a cross-sectional illustration of the embodiment of theintragastric device depicted in FIG. 2G;

FIG. 2I is an illustration of another embodiment of an intragastricdevice in an exemplary pre-deployment configuration;

FIG. 2J is an illustration of the intragastric device of FIG. 2I in anexemplary post-deployment configuration, depicting a spherical structurecomprised of spiral wires;

FIG. 2K is an illustration of another embodiment of an intragastricdevice in an exemplary pre-deployment configuration;

FIG. 2L is an illustration of the intragastric device of FIG. 2K in anexemplary post-deployment configuration, depicting a spherical structurecomprised of spiral strips;

FIG. 2M is an illustration of yet another embodiment of an intragastricdevice in an exemplary pre-deployment configuration;

FIG. 2N is an illustration of the intragastric device of FIG. 2M in anexemplary post-deployment configuration;

FIG. 2O is an illustration of one embodiment depicting an exemplarypost-deployment membrane covered intragastric device with varying sizedholes along its surface;

FIG. 2P is an illustration of another embodiment of an intragastricdevice in an exemplary post-deployment configuration having a dumbbellshape;

FIG. 2Q is an illustration of a first exemplary wire mesh structureshape, in accordance with one embodiment of the present specification;

FIG. 2R is an illustration of a second exemplary wire mesh structureshape, in accordance with one embodiment of the present specification;

FIG. 2S is an illustration of a third exemplary wire mesh structureshape, in accordance with one embodiment of the present specification;

FIG. 2T is an illustration of a fourth exemplary wire mesh structureshape, in accordance with one embodiment of the present specification;

FIG. 2U is an illustration of a fifth exemplary wire mesh structureshape, in accordance with one embodiment of the present specification;

FIG. 3A is an illustration of a wire mesh structure and coupled sleeveof an intragastric device in a post-deployment configuration inaccordance with one embodiment of the present specification, depictingthe wire mesh structure with the weave pattern as shown in FIG. 2B;

FIG. 3B is an illustration of a wire mesh structure and coupled sleeveof an intragastric device in a post-deployment configuration inaccordance with another embodiment of the present specification,depicting the wire mesh structure with the weave pattern as shown inFIG. 2C;

FIG. 3C is an illustration of a wire mesh structure and coupled sleeveof an intragastric device in a post-deployment configuration inaccordance with another embodiment of the present specification,depicting the wire mesh structure with the weave pattern as shown inFIG. 2D;

FIG. 3D is an illustration of a wire mesh structure and coupled sleeveof an intragastric device in a post-deployment configuration inaccordance with yet another embodiment of the present specification,depicting the wire mesh structure with the weave pattern as shown inFIG. 2E;

FIG. 4A is an illustration of a wire mesh structure with retrieval hookand coupled sleeve of an intragastric device in a post-deploymentconfiguration in accordance with one embodiment of the presentspecification, depicting the wire mesh structure with the weave patternas shown in FIG. 2B;

FIG. 4B is an illustration of a wire mesh structure with retrieval hookand coupled sleeve of an intragastric device in a post-deploymentconfiguration in accordance with another embodiment of the presentspecification, depicting the wire mesh structure with the weave patternas shown in FIG. 2C;

FIG. 4C is an illustration of a wire mesh structure with retrieval hookand coupled sleeve of an intragastric device in a post-deploymentconfiguration in accordance with another embodiment of the presentspecification, depicting the wire mesh structure with the weave patternas shown in FIG. 2D;

FIG. 4D is an illustration of a wire mesh structure with retrieval hookand coupled sleeve of an intragastric device in a post-deploymentconfiguration in accordance with yet another embodiment of the presentspecification, depicting the wire mesh structure with the weave patternas shown in FIG. 2E;

FIG. 5A is an illustration of a wire mesh structure with retrieval hook,coupled sleeve, and anti-migration component of an intragastric devicein a post-deployment configuration in accordance with one embodiment ofthe present specification, depicting the wire mesh structure with theweave pattern as shown in FIG. 2B;

FIG. 5B is an illustration of a wire mesh structure with retrieval hook,coupled sleeve, and anti-migration component of an intragastric devicein a post-deployment configuration in accordance with another embodimentof the present specification, depicting the wire mesh structure with theweave pattern as shown in FIG. 2C;

FIG. 5C is an illustration of a wire mesh structure with retrieval hook,coupled sleeve, and anti-migration component of an intragastric devicein a post-deployment configuration in accordance with another embodimentof the present specification, depicting the wire mesh structure with theweave pattern as shown in FIG. 2D;

FIG. 5D is an illustration of a wire mesh structure with retrieval hook,coupled sleeve, and anti-migration component of an intragastric devicein a post-deployment configuration in accordance with yet anotherembodiment of the present specification, depicting the wire meshstructure with the weave pattern as shown in FIG. 2E;

FIG. 6A is an illustration of one embodiment depicting a first exemplaryconfiguration of the wire mesh structure;

FIG. 6B is an illustration of one embodiment depicting a secondexemplary configuration of the wire mesh structure;

FIG. 6C is an illustration of one embodiment depicting a third exemplaryconfiguration of the wire mesh structure;

FIG. 6D is an illustration of one embodiment depicting a fourthexemplary configuration of the wire mesh structure;

FIG. 6E is an illustration of one embodiment depicting a fifth exemplaryconfiguration of the wire mesh structure;

FIG. 6F is an illustration of one embodiment depicting the expandedconfiguration of the wire mesh structure of FIG. 6E;

FIG. 6G is an illustration of one embodiment depicting a sixth exemplaryconfiguration of the wire mesh structure;

FIG. 6H is an illustration of one embodiment depicting a seventhexemplary configuration of the wire mesh structure;

FIG. 6I is an illustration of one embodiment depicting an eighthexemplary configuration of the wire mesh structure;

FIG. 6J is an illustration of one embodiment depicting a ninth exemplaryconfiguration of the wire mesh structure;

FIG. 6K is an illustration of one embodiment depicting a tenth exemplaryconfiguration of the wire mesh structure;

FIG. 6L is an illustration of one embodiment depicting an eleventhexemplary configuration of the wire mesh structure;

FIG. 6M is an illustration of a twelfth exemplary wire mesh weavepattern in accordance with one embodiment of the present specification;

FIG. 6N is an illustration of a thirteenth exemplary wire mesh weavepattern in accordance with one embodiment of the present specification;

FIG. 6O is an illustration of a fourteenth exemplary wire mesh weavepattern in accordance with one embodiment of the present specification;

FIG. 6P is an illustration of a fifteenth exemplary wire mesh weavepattern in accordance with one embodiment of the present specification;

FIG. 6Q is an illustration of a sixteenth exemplary wire mesh weavepattern in accordance with one embodiment of the present specification;

FIG. 6R is an illustration of a seventeenth exemplary wire mesh weavepattern in accordance with one embodiment of the present specification;

FIG. 6S is an illustration of an eighteenth exemplary wire mesh weavepattern in accordance with one embodiment of the present specification;

FIG. 7A is a flow chart illustrating the steps involved during themanufacture of an intragastric device having a corrosion-resistantcoating, in accordance with one embodiment of the present specification;

FIG. 7B is a flow chart illustrating the steps involved during themanufacture of an intragastric device having a corrosion-resistantcoating, in accordance with another embodiment of the presentspecification;

FIG. 7C is a flow chart illustrating the steps involved during themanufacture of an intragastric device having a corrosion-resistantcoating, in accordance with yet another embodiment of the presentspecification;

FIG. 8 is an oblique side view illustration of the proximal end of anintragastric device in a post-deployment configuration in accordancewith one embodiment of the present specification, depicting first andsecond openings in the proximal and distal ends, respectively of a wiremesh structure of the device;

FIG. 9 is another oblique side view illustration of the proximal end ofan intragastric device in a post-deployment configuration in accordancewith one embodiment of the present specification;

FIG. 10 is an illustration of one embodiment of an intragastric deviceof the present specification in a post-deployment configuration,depicting a sleeve component as it would conform to the shape of theproximal small intestine;

FIG. 11 is a side view illustration of one embodiment of an intragastricdevice of the present specification in a post-deployment configuration,depicting a wire mesh structure, retrieval hook, coupled sleeve, anddistally sloping anti-migration disc;

FIG. 12 is an oblique side view illustration of one embodiment of anintragastric device of the present specification in a post-deploymentconfiguration, depicting a second opening at the distal end of a wiremesh structure and the underside of a distally sloping anti-migrationdisc;

FIG. 13A is an illustration of a wire mesh structure in apost-deployment configuration with a distally sloping anti-migrationdisc attached to its distal end, in accordance with one embodiment ofthe present specification;

FIG. 13B is an illustration of a wire mesh structure in apost-deployment configuration with a proximally sloping anti-migrationdisc attached to its distal end, in accordance with one embodiment ofthe present specification;

FIG. 14 is an illustration depicting the expansion of an intragastricdevice having a half sphere wire mesh structure, anti-migrationcomponent, and sleeve during deployment, in accordance with oneembodiment of the present specification;

FIG. 15A is an illustration of a first exemplary anti-migrationcomponent shape in a post-deployment configuration, in accordance withone embodiment of the present specification;

FIG. 15B is an illustration of a second exemplary anti-migrationcomponent shape in a post-deployment configuration, in accordance withone embodiment of the present specification;

FIG. 15C is an illustration of a third exemplary anti-migrationcomponent shape in a post-deployment configuration, in accordance withone embodiment of the present specification;

FIG. 15D is an illustration of a fourth exemplary anti-migrationcomponent shape in a post-deployment configuration, in accordance withone embodiment of the present specification;

FIG. 15E is an illustration of a fifth exemplary anti-migrationcomponent shape in a post-deployment configuration, in accordance withone embodiment of the present specification;

FIG. 15F is an illustration of a sixth exemplary anti-migrationcomponent shape in a post-deployment configuration, in accordance withone embodiment of the present specification;

FIG. 15G is an illustration of a seventh exemplary anti-migrationcomponent shape in a post-deployment configuration, in accordance withone embodiment of the present specification;

FIG. 15H is an illustration of an eighth exemplary anti-migrationcomponent shape in a post-deployment configuration, in accordance withone embodiment of the present specification;

FIG. 16 is an illustration of a wire mesh structure in a post-deploymentconfiguration with a flower-shaped, proximally sloping anti-migrationdisc attached to its distal end, in accordance with one embodiment ofthe present specification;

FIG. 17A is an illustration of a sleeve component of an intragastricdevice in a post-deployment configuration in accordance with oneembodiment of the present specification, depicting horizontal andvertical support elements, a proximal first opening, and a side secondopening proximate the distal end of the sleeve;

FIG. 17B is an illustration of a sleeve component of an intragastricdevice in a post-deployment configuration in accordance with oneembodiment of the present specification, depicting horizontal andvertical support elements, a proximal first opening, and a secondopening at the distal end of the sleeve;

FIG. 17C is an illustration of a sleeve component of an intragastricdevice in a post-deployment configuration in accordance with oneembodiment of the present specification, depicting a wire mesh support,a proximal first opening, and a side second opening proximate the distalend of the sleeve;

FIG. 17D is an illustration of a sleeve component of an intragastricdevice in a post-deployment configuration in accordance with oneembodiment of the present specification, depicting a wire mesh support,a proximal first opening, and a second opening at the distal end of thesleeve;

FIG. 17E is an illustration of a sleeve component of an intragastricdevice in a post-deployment configuration in accordance with oneembodiment of the present specification, depicting a spiral wiresupport, a proximal first opening, and a side second opening proximatethe distal end of the sleeve;

FIG. 17F is an illustration of a sleeve component of an intragastricdevice in a post-deployment configuration in accordance with oneembodiment of the present specification, depicting a spiral wiresupport, a proximal first opening, and a second opening at the distalend of the sleeve;

FIG. 18A is an illustration of another embodiment of an intragastricdevice with an attached sleeve in an exemplary post-deploymentconfiguration;

FIG. 18B is a cross-sectional illustration of the embodiment of anintragastric device with an attached sleeve in an exemplarypost-deployment configuration of FIG. 18A;

FIG. 18C is an illustration of an embodiment of an intragastric devicehaving a dumbbell shape with an attached sleeve in an exemplarypost-deployment configuration;

FIG. 18D is an illustration depicting various exemplary post-deploymentconfiguration intragastric devices in accordance with multipleembodiments of the present specification;

FIG. 18E is an illustration of another embodiment of the intragastricdevice with an attached sleeve in an exemplary pre-deploymentconfiguration;

FIG. 18F is an illustration of the intragastric device with an attachedsleeve of FIG. 18E in an exemplary post-deployment configuration;

FIG. 19A is an illustration of one embodiment of an intragastric devicein a post-deployment configuration having first and second sleevescoupled to a wire mesh structure;

FIG. 19B is an illustration of one embodiment of an intragastric devicein a post-deployment configuration having one sleeve coupled to a wiremesh structure at a distance distally away from said wire meshstructure;

FIG. 19C is an illustration of another embodiment of an intragastricdevice in a post-deployment configuration having one sleeve coupled to awire mesh structure at a distance distally away from said wire meshstructure;

FIG. 20 is an illustration of one embodiment of an intragastric devicein a post-deployment configuration having a wire mesh structure and asleeve coupled to the wire mesh structure and a membrane covering boththe sleeve and wire mesh structure;

FIG. 21 is an illustration of one embodiment of an intragastric devicein a post-deployment configuration having a half sphere wire meshstructure and a sleeve coupled to the wire mesh;

FIG. 22 is an illustration of one embodiment of an intragastric devicein a post-deployment configuration having a wire mesh structure and asleeve coupled to the wire mesh structure and a membrane covering thesleeve and wire mesh structure, depicting a plurality of openings in themembrane;

FIG. 23A is an illustration of one embodiment of an intragastric devicein a post-deployment configuration having a wire mesh structure and asleeve coupled to the wire mesh;

FIG. 23B is an illustration of one embodiment of an intragastric devicein a post-deployment configuration having a wire mesh structure and asleeve coupled to the wire mesh structure, wherein the upper portion ofthe wire mesh structure comprises a wire mesh and the lower portioncomprises only a membrane;

FIG. 23C is an illustration of one embodiment of an intragastric devicein a post-deployment configuration having a wire mesh structure and asleeve coupled to the wire mesh structure, wherein the upper portion ofthe wire mesh structure has a greater radial strength than the lowerportion;

FIG. 24A is an illustration of a first exemplary double-wire meshstructure intragastric device in a post-deployment configuration inaccordance with one embodiment of the present specification;

FIG. 24B is an illustration of a second exemplary double-wire meshstructure intragastric device in a post-deployment configuration inaccordance with one embodiment of the present specification;

FIG. 24C is an illustration of a third exemplary double-wire meshstructure intragastric device in a post-deployment configuration inaccordance with one embodiment of the present specification;

FIG. 24D is an illustration of a fourth exemplary double-wire meshstructure intragastric device in a post-deployment configuration inaccordance with one embodiment of the present specification;

FIG. 24E is an illustration of a fifth exemplary double-wire meshstructure intragastric device in a post-deployment configuration inaccordance with one embodiment of the present specification;

FIG. 25 is an illustration of one embodiment of an intragastric devicein a post-deployment configuration having a wire mesh structure,anti-migration disc, and sleeve, depicting a membrane covering thesleeve and a lower portion of the wire mesh structure;

FIG. 26A is an illustration of a portion of a patient's gastrointestinaltract following a sleeve gastrectomy procedure;

FIG. 26B is an illustration of a portion of a patient's gastrointestinaltract following a roux-en-y gastric bypass (RGB) procedure;

FIG. 27 is an illustration of an intragastric device with an attacheddevice sleeve deployed in the stomach and duodenum following a sleevegastrectomy procedure;

FIG. 28A is an illustration of another embodiment of an intragastricdevice with a proximal tubular end and an attached device sleevedeployed in the stomach and duodenum following a sleeve gastrectomyprocedure;

FIG. 28B is an illustration of an embodiment of an intragastric devicewith a proximal tubular end and an attached device sleeve similar to thedevice of the embodiment of FIG. 28A, depicting the device deployed inthe stomach and duodenum following a sleeve gastrectomy procedure;

FIG. 29 is an illustration of another embodiment of an intragastricdevice with an attached device sleeve deployed in the gastric pouchfollowing a roux-en-y gastric bypass (RGB) procedure;

FIG. 30 is an illustration of another embodiment of an intragastricdevice in a post-deployment configuration with an attached device sleevefor implantation into the gastric pouch of a patient following aroux-en-y gastric bypass (RGB) procedure;

FIG. 31 is an illustration of an expanded wire mesh structure of a firstintragastric device and a constricted wire mesh structure of a secondintragastric device coupled to the distal end of an implantationcatheter, in accordance with one embodiment of the presentspecification;

FIG. 32 is an illustration of an intragastric device with a partiallyconstrained wire mesh structure on a delivery catheter, in accordancewith one embodiment of the present specification;

FIG. 33A is an illustration of a first exemplary delivery catheter foran intragastric device, in accordance with one embodiment of the presentspecification;

FIG. 33B is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery catheter of FIG. 33A, inaccordance with one embodiment of the present specification;

FIG. 34A is an illustration of a second exemplary delivery catheter foran intragastric device, in accordance with one embodiment of the presentspecification;

FIG. 34B is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery catheter of FIG. 34A, inaccordance with one embodiment of the present specification;

FIG. 35A is an illustration of a third exemplary delivery catheter foran intragastric device, in accordance with one embodiment of the presentspecification;

FIG. 35B is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery catheter of FIG. 35A, inaccordance with one embodiment of the present specification;

FIG. 35C is a flow chart illustrating the steps involved in delivering awire mesh structure and sleeve separately and assembling an intragastricdevice within a patient's gastrointestinal tract;

FIG. 36 is an illustration of one embodiment of an intragastric devicein an exemplary pre-deployment configuration;

FIG. 37 is an illustration of another embodiment of an intragastricdevice in an exemplary pre-deployment configuration;

FIG. 38 is an illustration of one embodiment of an intragastric devicein an exemplary post-deployment configuration;

FIG. 39 is an illustration of another embodiment of an intragastricdevice in an exemplary post-deployment configuration;

FIG. 40A is an illustration of a gastric device removal catheterattached to an intragastric device in an exemplary post-deploymentconfiguration;

FIG. 40B is an illustration of a gastric device removal catheterattached to an intragastric device in an exemplary pre-deploymentconfiguration;

FIG. 41 is an illustration of one embodiment of an intragastric devicebeing deployed in a stomach;

FIG. 42 is an illustration of one embodiment of a fully deployedintragastric device in a stomach;

FIG. 43A is an illustration of an intragastric device having an ovalshaped wire mesh structure deployed in the gastrointestinal tract of apatient, in accordance with one embodiment of the present specification;

FIG. 43B is an illustration of an intragastric device having a footballshaped wire mesh structure deployed in the gastrointestinal tract of apatient, in accordance with one embodiment of the present specification;

FIG. 44 is an illustration of one embodiment of an intragastric devicewith an attached sleeve being deployed in an upper gastrointestinaltract;

FIG. 45 is an illustration of one embodiment of a fully deployedintragastric device with an attached sleeve in an upper gastrointestinaltract;

FIG. 46 is an illustration of one single exemplary intragastric devicebeing attached to a previously deployed single intragastric device in astomach;

FIG. 47 is an illustration of an exemplary fully deployed combinedintragastric device in a stomach;

FIG. 48 is an illustration of one embodiment of an intragastric devicein a post-deployment configuration having a first type ofcircumferential constraining mechanism positioned on a wire meshstructure;

FIG. 49 is an illustration of one embodiment of an intragastric devicein a post-deployment configuration having a second type ofcircumferential constraining mechanism positioned on a wire meshstructure;

FIG. 50 is an illustration of an exemplary intragastric device beingremoved from a stomach;

FIG. 51 is a flow chart illustrating the steps involved during retrievalof an intragastric device in accordance with one embodiment of thepresent specification;

FIG. 52 is an illustration of one embodiment of a wire mesh structure ofan intragastric device being restrained by circumferential constrictingmechanisms prior to removal;

FIG. 53 is an illustration of one embodiment of a retrieval device and aportion of a wire mesh structure partially constrained by acircumferential constricting mechanism;

FIG. 54 is an illustration of one embodiment of a grasping hook of aretrieval device engaging a tie that has been secured to the retrievalhook of a wire mesh structure of an intragastric device;

FIG. 55A is an illustration of a wire mesh structure of an intragastricdevice partially drawn into the distal end of a retrieval device, inaccordance with one embodiment of the present specification;

FIG. 55B is a flow chart illustrating the steps involved in retrieving adeployed intragastric device using the retrieval device of FIG. 54 , inaccordance with one embodiment of the present specification;

FIG. 56A is an illustration of a first exemplary circumferentialconstricting mechanism in accordance with one embodiment of the presentspecification;

FIG. 56B is an illustration of the first exemplary circumferentialconstricting mechanism of FIG. 56A, depicting the circumferentialconstricting mechanism tied about a portion of a wire mesh structure;

FIG. 57 is an illustration of a second exemplary circumferentialconstricting mechanism in accordance with one embodiment of the presentspecification;

FIG. 58 is an illustration of a third exemplary circumferentialconstricting mechanism in accordance with one embodiment of the presentspecification;

FIG. 59A is an illustration of a fourth exemplary circumferentialconstricting mechanism in accordance with one embodiment of the presentspecification;

FIG. 59B is an illustration of the exemplary circumferentialconstricting mechanism of FIG. 59A with a portion of the elongate bodyslid horizontally into the second section of the central opening,thereby locking the circumferential constricting mechanism;

FIG. 60 is an illustration of one embodiment of a retrieval devicehaving a grasping hook and clampers at its distal end;

FIG. 61 is an illustration of one embodiment of a retrieval device witha grasping hook engaging the free end of a circumferential constrictingmechanism positioned about a wire mesh structure;

FIG. 62 is an illustration of one embodiment of a retrieval deviceapplying a clamp to a circumferential constricting mechanism positionedabout a wire mesh structure of an intragastric device;

FIG. 63 is an illustration of one embodiment of a restrained wire meshstructure with a clamp applied to the free end of a circumferentialconstricting mechanism positioned about the wire mesh structure;

FIG. 64 is a flow chart illustrating the steps involved in retrieving adeployed intragastric device using the retrieval device of FIG. 60 , inaccordance with one embodiment of the present specification;

FIG. 65A is cross-section illustration of a retrieval device forremoving an intragastric device in accordance with one embodiment of thepresent specification;

FIG. 65B is a cross-section illustration of an exploded view of thecatheter component of the retrieval device of FIG. 65A;

FIG. 65C is a cross-section illustration of an assembled view of thecatheter component of the retrieval device of FIG. 65A;

FIG. 65D is a cross-section illustration of the overtube of theretrieval device of FIG. 65A, depicting a deflated balloon at the distalend of the overtube;

FIG. 65E is a cross-section illustration of the overtube of theretrieval device of FIG. 65A, depicting an inflated balloon at thedistal end of the overtube; and,

FIG. 66 is a flow chart illustrating the steps involved in removing anintragastric device from a patient using the retrieval device of FIG.65A, in accordance with one embodiment of the present specification.

DETAILED DESCRIPTION

In one embodiment, the present specification is directed toward anintragastric device of dynamic weight used in obese patients to induceweight loss. In various embodiments, the intragastric device comprises aporous three dimensional structure having a pre-deployment shape and apost-deployment shape. In one embodiment, the porous three dimensionalstructure is a non-inflatable wire mesh structure, or a spiral structuremade of shape memory metal or shape memory polymer that changes from apre-deployment compressed cylindrical shape to a post-deployment sphere,oval, kidney bean or any predefined shape of significant volume. Inanother embodiment, the intragastric device is made of a plasticmaterial or a polymer such as polyether ether ketone (PEEK) or polyesteror a bioresorbable material. The device changes back and forth from thepre-deployment to post-deployment shape by minimal mechanical forceand/or temperature changes arising from the room temperaturepre-deployment shape to the body temperature post-deployment shape. Thedevice is delivered endoscopically to the stomach via a catheter. Thedevice can be placed through the endoscope, over an endoscope or over aguidewire with endoscopic or fluoroscopic guidance/assistance.

The device has a pre-deployment compressed shape to facilitate insertionand a post-deployment expanded shape that resides in the gastric lumen.Post-deployment volume of the device is significantly larger thanpre-deployment volume. In one embodiment, the post-deployment device hasa volume of at least 100 mL. The post-deployment device occupies asignificant volume in the stomach, thereby reducing available gastricvolume available for storage of ingested food. This restricts the amountof food intake, inducing satiety and curbing one's appetite. In oneembodiment, the device is also designed to intermittently, with gastricperistalsis, slow or block the passage of the food from the stomach intothe small intestine, thereby slowing gastric emptying.

In one embodiment, the device comprises a shape memory metal andself-expands once deployed to change from the pre-deployment shape tothe post-deployment shape. In another embodiment, the device comprises atemperature sensitive metal that is cooled in its pre-deployment shapeand then self-expands when exposed to human body temperature to achieveits post-deployment shape. In another embodiment, an expansion tool isused to apply minimal mechanical force to change the device shape fromits pre-deployment shape to its post-deployment shape. In anotherembodiment, a plastic, polymer, carbon fiber or a bioresorbable materialis used to construct the intragastric device.

In one embodiment, the wire structure contains differently weightedmaterial to assist in proper positioning within the stomach. In oneembodiment, lighter weighted material is positioned at the top of thewire structure proximate to the top openings and heavier weightedmaterial is positioned at the bottom of the structure, proximate to thebottom openings. This differential weighting insures that the devicewill be properly situated within the stomach to effectuate the intendedeffect of slower gastric emptying. In addition, the differentialweighting provides for proper gastric positioning without the need ofphysically anchoring the wire mesh structure to the stomach wall. Thedifferential weight property can also be provided by the ingested foodmaterial that enters the device and is selectively accumulated towardthe bottom of the device facilitated by the gravitational pull. Thedifferential weight can also be provided by using different amounts ofmaterial in the top and bottom halves. The wire mesh structure is freeto move about within the stomach while still maintaining its correct topto bottom alignment facilitated by the gravitational pull.

In one embodiment, the device comprises a wire mesh structure which,when in the post-deployment shape, includes mesh openings between thewires of the mesh structure. In one embodiment, the mesh openings aregreater than 1 mm in diameter. In one embodiment, the wires of the wiremesh structure are coated with a corrosion-resistant material. Thecorrosion resistant material prevents exposure and subsequentdegradation of the wires of the wire mesh structure from acidic gastriccontents once deployed. The corrosion-resistant material completelycovers the wires of the wire mesh but does not cover the mesh openings.In various embodiments, the corrosion-resistant material comprisessilicone, parylene, polyester, polyether ether ketone (PEEK), a medicalgrade epoxy, ceramic, an additional metal, or any other suitable,flexible corrosive resistant material. In one embodiment, the coatingmetal is tantalum. Tantalum provides corrosive resistance andradiopacity. In one embodiment, wherein the coating is ceramic, theceramic coating has a thickness of several angstroms. In variousembodiments, any one or combination of the above corrosive resistantmaterials is used to coat the metal of the wire mesh structure.

In one embodiment, the mesh openings are differentially structured toregulate the flow of food in and out of the mesh. In one embodiment, atleast one opening on the bottom half of the device is larger than any ofthe openings on the upper half of the device, allowing food entering themesh to exit without the need for further reduction in size of foodmaterial.

The present specification discloses a method for manufacturing anintragastric device comprising a wire mesh structure having acorrosion-resistant material coated over the wires. In one embodiment,the corrosion-resistant material is silicone. The method comprises thesteps of forming the wires into the post-deployment shape of the deviceand then coating the wires while taking care not to cover the meshopenings between the wires of the wire mesh. Covering and/or cloggingthe mesh openings is prevented by controlling the viscosity of thecorrosion-resistant material and by controlling the size of the meshopenings between the wires. If the viscosity of the material is too highand/or the size of the mesh openings is too small, thecorrosion-resistant material will become deposited over and will coverthe mesh openings, interfering with the functioning of the device. Ifthe viscosity is too low, the coating will be too thin to provideeffective protection to the metal. In one embodiment, an intragastricdevice is formed by a method comprising heat setting a shape memorymetal into a wire mesh structure having openings between the mesh wireswhich are in a range of 2-20 mm in diameter. The viscosity of thecorrosion-resistant material, in one embodiment, silicone, is controlledby varying the concentration of silicone and methylbenzene. In variousembodiments, the weight ratio of silicone to methylbenzene in thecorrosion-resistant material is in a range of 1:100-25:100. In oneembodiment, the weight ratio of silicone to methylbenzene in thecorrosion-resistant material is 8:100. To achieve the desired coatingthickness, the formed wire mesh structure is dipped multiple times intothe corrosion-resistant material to apply multiple layers of coating. Invarious embodiments, the final thickness of the corrosion-resistantmaterial coating is in a range of 0.001-0.010 inches.

In another embodiment, the corrosion-resistant material is applied byvapor deposition. In one embodiment, the corrosion-resistant material isparylene. Using vapor deposition lowers the likelihood that the meshopenings will be covered by the coating as the vapor passes through theopenings and clings to the metal wires. The final thickness of thecoating is determined by the amount of time spent depositing the coatingand the amount of coating material used.

In another embodiment, the two methods described above are combined toapply the corrosion resistant materials. First, the fully formed wiremesh structure is dipped multiple times into silicone. Once the siliconecoating has dried, parylene is vapor deposited onto the structure toprovide additional protection. In another embodiment, parylene vapor isdeposited first and then the wire mesh structure is dipped in siliconeto apply the coating.

In one embodiment, the present specification is directed toward a wiremesh or spiral structure with an exterior housing structure that isdefined by openings, holes, voids or spaces of varying sizes. In oneembodiment, the wire mesh or spiral structure has larger spaces oropenings within its upper portion and smaller spaces within its bottomportion. In another embodiment, the wire mesh or spiral structure hasspaces or openings within its upper portion which are equal in size tospaces within its bottom portion. In yet another embodiment, the wiremesh or spiral structure has smaller spaces or openings within its upperportion and larger spaces within its bottom portion. In one embodiment,the hole or opening at the bottom of the wire mesh structure, designedfor the exit of food from the device, is larger than any other hole inthe device. By having a larger hole at the bottom of the device than atthe top of the device, the device does not affect or control the exit offood out of the device based on the size of the food particle. Anyparticle of food adequately sized to freely enter the device through anopening proximate the top of the device will have no problem easilyexiting from the larger hole at the bottom of the device. The spaces oropenings within the upper portion of the device are preferably alignedwith, and directed toward, the esophagus, the cardia, the fundus or thebody of the stomach and the spaces or openings within the bottom portionof the device are preferably aligned with, and directed toward, thegastric antrum or the intestines.

These spaces or openings provide two additional benefits beyond thefeeling of satiety provided by the expanded second configuration. First,differential sizes or numbers resulting in differential surface area ofthe upper and lower openings enable the device to act like a timerelease capsule. In the embodiment having larger openings in the upperportion than in the bottom portion, the larger surface area of theopenings toward the top two-thirds of the structure permit a largervolume of food to enter into the device, as compared to the volume offood permitted to leave the device via the smaller surface area of theopenings that define the bottom of the device, thereby making the devicea temporary storage unit with a delayed release of the nutrients. As thestomach grinds solid food into liquid food, or chyme, the chyme passesinto and is sequestered inside the intragastric device. The chyme isthen slowly released back into the stomach, thereby delaying gastricemptying and inducing satiety. The gastric emptying can also becontrolled by varying both the number and size of these openings, holes,spaces or voids to differentially control the inflow and outflow of thefood from the device. In essence, the ratio of the surface area of theinflow and the outflow as calculated by the size and the number ofinflow and outflow opening controls the rate of emptying from the deviceand hence the gastric emptying. Additionally, in one embodiment, atleast one opening at the bottom of the device is larger than any of theopenings on the top of the device, allowing any food particle enteringthe device to exit the device without the need for further reduction insize, thus preventing food trapping or prolonged stasis.

An additional embodiment of the device has large holes or openings inthe middle and smaller openings in the top and bottom halves, therebyallowing the partially digested food to enter in the middle portion withthe option to leave from either the top or the bottom half. In anotherembodiment the top two-thirds of the device has an opening but the lowerone-third of the device has a membrane without any openings that storesthe partially digested food in the upright position as a bowl andreleases the food back through the same openings in the top two thirdsof the device when the patient is supine. In addition, liquid foods,such as ice cream, will also be sequestered into the dependent portionof the device and released into the stomach more slowly at a later time.

Second, the varying shape, size and number of the openings or spaces inthe wire mesh structure allow the device to store ingested food andundergo meal induced dynamic weight change. The device will have agreater weight during and post feeding resulting in an appropriatelytimed feeling of fullness or satiety. Heavier intra-gastric devices areassociated with more satiety and weight loss however they have moreside-effects such as nausea and abdominal pain. Slowly, as the food isreleased out of the device, the weight of the device will decrease overtime and return to its baseline weight. Eventually, the device will havea lower weight during fasting, diminishing the side effects commonlyassociated with an intragastric device, improving patient tolerance.Conventional water filled intragastric balloons are heavier than airfilled balloons resulting in a greater feeling of satiety and weightloss but patients suffer from increased side effects resulting in higherintolerance and the need for premature removal. Air filled balloons arelighter and therefore more tolerable, but are less effective in inducingsatiety and hence weight loss. The intragastric devices of the presentspecification improve upon both devices by inducing a greater and morenormalized feeling of satiety during feeding and post-feeding stageswhile reducing side effects during the fasting stage.

In another embodiment, the present specification is directed toward awire mesh or spiral structure partially encompassed, housed, orotherwise enclosed by a membrane. When expanded into the post-deploymentconfiguration, the membrane contains opening, holes, voids, or spacesproximate to the top of the device and holes proximate to the bottom ofthe device. The openings on the top of the device are preferably alignedwith, and directed toward, the esophagus, cardia, fundus or the body ofthe stomach and the openings at the bottom of the device are preferablyaligned with, and directed toward, the antrum or pylorus of the stomachor the small intestines. In one embodiment, the openings in the membraneproximate the top of the device have a larger surface area than theopenings in the membrane proximate the bottom of the device. In anotherembodiment, the openings in the membrane proximate the top of the deviceare equal in surface area to the openings in the membrane proximate thebottom of the device. In yet another embodiment, the openings in themembrane proximate the top of the device have a smaller surface areathan the openings in the membrane proximate the bottom of the device.

These openings provide two additional benefits beyond the feeling ofsatiety provided by the expanded post-deployment configuration. First,the device with differentially sized membrane opening, holes or voidsacts as a time release capsule. In the embodiment having a largersurface area of openings in the membrane proximate the top of the devicethan proximate the bottom of the device, more food enters into thedevice from the large surface area of the openings at the top than exitsfrom the smaller surface area of the openings at the bottom, resultingin a device that functions as a temporary storage unit with a delayedrelease of nutrients. As the stomach grinds solid food into liquid food,or chyme, the chyme is sequestered inside the wire mesh device. Thechyme is then slowly released back into the stomach, thereby delayinggastric emptying and inducing satiety. In addition, liquid foods, suchas ice cream, will also be sequestered into the dependent portion of thedevice and released back into the stomach more slowly.

Second, the two sets of openings in the wire mesh structure membraneallow the device to undergo dynamic weight change. The device will havea greater weight during and post feeding resulting in an appropriatelytimed feeling of fullness or satiety. Slowly, as the food exits thedevice, the weight of the device will decrease over time. Eventually,the device will have a lower weight during fasting, diminishing the sideeffects commonly associated with an intragastric device, such as nauseaand pain. Conventional water filled intragastric balloons are heavierthan air filled balloons resulting in a greater feeling of satiety butpatients suffer from increased side effects. Air filled balloons arelighter and therefore more tolerable, but are less effective in inducingsatiety. The intragastric devices of the present specification improveupon both devices by inducing a greater and more normalized feeling ofsatiety during the feeding and post-feeding stage while reducing theside effects.

In another embodiment, the wire mesh structure has portions that arecompletely covered by a membrane and some portions that are not,resulting in differential release of food. In one embodiment, the topand bottom of the wire mesh structure are completely covered by themembrane and the middle of the structure has openings in the membrane toallow the passage of food. In another embodiment, the wire meshstructure is 90-99% covered by the membrane, leaving only a small areafor food passage, thereby increasing the time for gastric emptying.

In another embodiment, the membrane covering the wire mesh structure hasa ring of large openings in the upper hemisphere of the structure and aring of smaller openings in the bottom hemisphere of the structure. Inanother embodiment, the membrane covering the wire mesh structure has aring of small openings in the upper hemisphere of the structure and aring of larger openings in the bottom hemisphere of the structure. Inanother embodiment, the membrane covering the wire mesh structure has aring of openings in the upper hemisphere of the structure and a ring ofopenings, equal in size to the upper openings, in the bottom hemisphereof the structure.

In another embodiment, the membrane covering the wire mesh structure hasa greater number of openings in the upper hemisphere of the structureand fewer openings in the bottom hemisphere of the structure. In anotherembodiment, the membrane covering the wire mesh structure has feweropenings in the upper hemisphere of the structure and a greater numberof openings in the bottom hemisphere of the structure. In anotherembodiment, the membrane covering the wire mesh structure has the samenumber of openings in the upper hemisphere of the structure as in thebottom hemisphere of the structure.

In another embodiment, the membrane covering the wire mesh structure hasa larger surface area of openings in the upper hemisphere of thestructure and a smaller surface area of openings in the bottomhemisphere of the structure. In another embodiment, the membranecovering the wire mesh structure has a smaller surface area of openingsin the upper hemisphere of the structure and a larger surface area ofopenings in the bottom hemisphere of the structure. In anotherembodiment, the membrane covering the wire mesh structure has the samesurface area of openings in the upper hemisphere of the structure as inthe bottom hemisphere of the structure. These different configurationsallow control of the rate of entry and/or exit of food into and out ofthe device, resulting in delayed gastric emptying and dynamic weightchange of the wire mesh structure.

The gastric fundus is involved in the release of various gut hormonessuch as “hunger hormones”, ghrelin, orexin and PYY 3-36, and “satietyhormones”, e.g., leptin, obestatin, and nesfatin-1. The release of thesehormones is mediated by contact of gastric mucosa with various nutrientsin the ingested food. The top portion of the wire mesh structure willprevent sequestered food from coming into contact with the gastriccardia and fundus. This results in physiological exclusion of thegastric cardia and fundus, a mechanism thought to play a role in satietyand weight loss and one of the mechanisms in play in RGB gastric bypasssurgery.

In another embodiment, layers of a membrane act as a flap valvecontrolling the directionality of the movement of the food in thevarious portions of an intragastric device. Just like the size of theopenings, the size, shape, position and directionality of the valves canbe varied to achieve desired gastric emptying effects.

In another embodiment, the intragastric device further includes ananti-migration component coupled to a portion of its distal end. Theanti-migration component, similar to the wire mesh of the intragastricdevice, is configurable between a first, compressed configuration fordelivery, and a second, expanded configuration once deployed. Theanti-migration component functions as a physical stopper preventingpassage of the intragastric device through the pylorus. In variousembodiments, the anti-migration component has a diameter that is greaterthan the diameter of a relaxed pylorus. In one embodiment, theanti-migration component comprises an extension of the wire meshstructure of the intragastric device. In another embodiment, theanti-migration component is a separate piece of wire mesh which isattached to a portion of the distal end of the intragastric device. Invarious embodiments, the anti-migration component has a shapeapproximating a bumper, half-bumper, disc, saucer, or any other shapewhich will prevent migration of the device past the pylorus.

In another embodiment, a sleeve can be attached to the intragastricdevice, where the sleeve extends from the stomach through the duodenumand into the jejunum. In one embodiment, the sleeve functions to transitthe sequestered chyme from the wire mesh structure directly to themid-jejunum. In another embodiment, the sleeve is coupled to theintragastric device but does not directly receive food from the device.In this embodiment, the proximal end of the sleeve is distal to thedevice and receives food directly from either the stomach or theduodenum. The food entering the sleeve exits at the distal end,preferably into the jejunum, bypassing a portion of the small intestine.

The sleeve therefore acts to bypass portions of the gastrointestinal(GI) tract in order to limit the absorption of specific materials in theintestine. The benefits provided by a sleeve are similar to thoseprovided by Roux-en-Y gastric bypass surgery, namely, weight loss andimprovement of type II diabetes. These benefits are accomplished in atleast two ways.

First, bypass of the duodenum and proximal jejunum improves type IIdiabetes by changing the hormone release from the proximal portion ofthe small intestine. This may also induce weight loss by inhibiting ordecreasing the release of pacreatico-biliary secretions and inducingmaldigestion and malabsorption. Second, the sleeve acts to releaseundigested nutrients into the mid-jejunum, improving type II diabetes bychanging the hormone release from the mid portion of the smallintestine. This may induce weight loss by maldigestion and malabsorptionof these nutrients. While conventional sleeve devices may perform someof these functions, conventional sleeves must be anchored in the GItract to avoid migration. Anchoring often results in complications,including infection, bleeding, perforation, and, if not anchoredcorrectly, migration of the sleeve leading to possible obstruction anddeath. In various embodiments of the present specification, the sleeveis physically attached or coupled to the intragastric device, where theintragastric device serves as the anchor for the sleeve. This eliminatesthe need for the sleeve to be physically anchored to the GI tract,eliminating the associated complications. In addition, the intragastricdevices with sleeves of the present specification offer functionaladvantages over conventional sleeves by concurrently controlling foodand calorie intake, inducing satiety, and controlling gastric emptying,which is not accomplished by traditional sleeve devices. The anchorlessdevice and/or sleeve system is not fixed to any portion of thegastrointestinal wall and is free to move relative to thegastrointestinal wall at all times.

Conventional sleeves are also typically very thin and formless. Inessence, these conventional sleeves are formless, thin plastic coversthat are physically anchored to the gastrointestinal (GI) tract,introducing the associated risks described above. Conventional sleevesmust be very thin and formless so that they do not pull or tug on theanchoring points, causing failure of the anchor and/or trauma to the GItissue at the anchor site. Additionally, these sleeves could twist,buckle or kink resulting in blockage of the sleeve and a functionalfailure. A thick or structured sleeve without food or filled with foodwould experience drag during peristalsis. The added weight of such asleeve, if anchored to the GI tract, would result in increased trauma tothe tissue at the anchoring site and anchor failure. As discussed, thesleeves disclosed in the present specification are physically coupled tothe wire mesh structure of the intragastric device and therefore do notneed to be anchored directly to the gastrointestinal wall, eliminatingsaid risks. In fact, additional weight and/or structure included in thesleeve would pull on the intragastric device, positioning it at thedesired location just proximal to the pylorus. Therefore, in variousembodiments, the sleeves of the present specification include horizontalsupport elements, vertical support elements, wire mesh support, spiralmesh support, weighted distal end, and/or any other structuralcomponents that would provide the sleeves with structural integrity,preventing the sleeve from permanently kinking, buckling or twisting.

In another embodiment, the intragastric device has multiple opening,holes, voids or spaces in the top half and a membrane with at least oneopening, hole, or void in the bottom half where the bottom openingdirects the food preferentially into the sleeve device. In thisembodiment, the bottom half of the intragastric device acts as a funnel,collecting all the food entering the device through the top half in thebottom half and preferentially releasing it into the sleeve which inturn will deliver the food/nutrients to the mid small intestine thusbypassing the proximal small intestine. In another embodiment withmultiple sleeves, the proximal sleeve may release the food into asecond, distal sleeve.

In one embodiment, the entire intragastric device is covered by amembrane with openings that have valves throughout the device directingthe food into the intragastric device where it is sequestered and ispreferentially emptied through the opening in the bottom half of thedevice into the sleeve, delivering it to the mid small bowel thusbypassing the proximal small intestine. In this embodiment, theintragastric device sequesters the nutrients/food and, through thesleeve attachment, empties them into the mid small intestine.

The above two embodiments mimic Roux-en-Y gastric bypass (RGB) surgeryby creating gastric restriction and isolation of the gastric fundus andbypassing the proximal small intestine, thus resulting in maximum weightloss and control of Type-II diabetes. In addition, the device has theability to regulate gastric emptying in a manner that cannot betraditionally achieved by RGB gastric bypass surgery. The controlled andprolonged release of nutrients into the mid and distal small bowel willresult in prolonged satiety via modulation of the release of guthormones such as “hunger hormones”, ghrelin, orexin, and PYY 3-36, and“satiety hormones”, e.g., leptin, obestatin, and nesfatin-1.

In one embodiment, a second intragastric device can be attached to analready deployed intragastric device, thereby increasing the volumeoccupied in the stomach. This serves to further limit the amount of foodingested by a patient and also further delays gastric emptying as foodflows from one intragastric device into the other before releasing backinto the stomach or into the attached sleeve device. This allows fortailoring the therapy to a specific patient's needs by increasing ordecreasing the volume of the intragastric devices. In addition, thisallows for the possibility of stepwise increases or decreases in thedevice based therapy based on therapeutic response and side-effectprofile. This is usually performed in the inflatable intragastricdevices by instilling or removing fluids. However, such devices do nothave the ability to regulate gastric emptying.

The present specification also discloses a retrieval device used toremove an intragastric device. The retrieval device is a catheterinserted per-orally or via an endoscope and passed through a proximal,and optionally through a distal, opening of the intragastric device. Thecatheter then engages and secures the proximal and distal end of theexpanded intragastric device and the intragastric device is thenconstrained back into its pre-deployed shape using mechanical force. Thereversion to its pre-deployed state in a shape memory device can befurther facilitated by instillation of cold fluid into the intragastricdevice, lowering the temperature of the intragastric device.

The present specification also discloses an intragastric device to beused following bariatric surgical procedures, such as, laparoscopicsleeve gastrectomy (LSG) and laparoscopic roux-en-y-gastric bypass (RGB)surgery. In one embodiment, the device includes a spherical or ovoidshaped wire mesh structure with a device sleeve attached to its distalend. In another embodiment, the device includes a tubular member havinga distal diameter greater than its proximal diameter that is designed tobe placed in a created gastric sleeve following LSG. In anotherembodiment, the device includes a proximal wire mesh structure designedto be positioned in a gastric pouch created following RGB surgery. Thedevice could restrict the volume of the pouch, exert pressure on thepouch inducing satiety or has a valve deployed at the exit of the meshto regulate the flow of the nutrients out of the pouch. The device couldbe anchored using barbs, t-tags, suture or other known anchoringmechanism into the gastric pouch.

In one embodiment, the intragastric device includes one or moreconstricting mechanisms that, when pulled upon, constrict the wire meshstructure of the device, thereby constricting the wire mesh structureinto a compressed configuration to facilitate retrieval of the device.

The present specification also discloses a method of retrieving anintragastric device by first constricting the device to a compressedconfiguration using one or more constricting mechanisms on the wire meshstructure and then removing the compressed device from the patientthrough the working channel of an endoscope.

The present specification discloses a device for use in the treatment ofobesity which functions by displacing volume in the stomach andproviding a bypass for food past the pylorus and a portion of the smallintestine. The device may have additional therapeutic effect byregulating the flow of the nutrients or food from the stomach into thesmall intestine. In one embodiment, the device displaces no less than10% of the stomach volume. In one embodiment, the device provides abypass for food such that ingested food enters the device at a firstpoint proximal to the pylorus and exits the device at a second pointdistal to the pylorus. In another embodiment the ingested food enters aportion of the device in the duodenum and exits in the jejunum. In oneembodiment, the device is partially mobile wherein said partial mobilityis defined as movement proximally and distally within the stomach of nomore than 15 inches. The mobility is along both the device's horizontaland vertical axes. Further, in one embodiment, at no point in time doesthe entirety of the functional device move into the duodenum.Optionally, in one embodiment, the device further acts to treat obesityby slowing the passage of food through the gastrointestinal (GI) tract.Optionally, in another embodiment, the device induces satiety byexerting intermittent pressure of stretch on a portion of thegastrointestinal wall. Optionally, in another embodiment, the functionaldevice at no point applies a constant pressure or radial force to thesame portion of the stomach or small intestine for a prolonged period oftime. The prolonged period is defined as >30 day but ideally should be<1 day. Optionally, in another embodiment, the device induces satiety byintermittently obstructing or slowing the passage of food from thestomach into the small intestine but at no time does the devicepermanently obstruct the flow of food from the stomach to smallintestine. In one embodiment, the device comprises a three dimensionalstructure defining an internal volume and having a proximal end and adistal end. The proximal end comprises at least one first opening andthe distal end comprises at least one second opening. In variousembodiments, said at least one first opening is smaller than said atleast one second opening. Food enters the device through said at leastone first opening, is sequestered within the device for a period oftime, and then exits the device through said at least one secondopening, thereby delaying gastric emptying and slowing the passage offood through the GI tract. In one embodiment, the device does not act tofilter food as a portion of the digested food passes alongside or aroundthe device. The larger food particles will flow around the device,rendering it an ineffective filter. As such, all food entering thedevice exits the device without the need for a size reduction. Having atleast one opening at the distal end that is larger than all the otheropenings allows for food to pass, even if there is an increase in sizedue to aggregation of food particles. In one embodiment, the device isimplanted endoscopically into the GI tract of a patient. To facilitatesuch an implantation, in various embodiments, the device is configurablebetween a first compressed configuration and a second expandedconfiguration once deployed. In addition, the device can be returnedsubstantially to its first compressed configuration for removal. Invarious embodiments, the diameter of the device in the compressedconfiguration is 25 mm or less.

Wire Mesh Structure

In various embodiments, the intragastric device comprises a porous threedimensional structure having a pre-deployment shape and apost-deployment shape. In one embodiment, the device, in thepost-deployment configuration, comprises a three dimensional wire meshstructure defining an internal volume and having a proximal end and adistal end. In another embodiment, the device, in the post-deploymentconfiguration, comprises a three dimensional spiral structure havingmetal wires or metal strips. In one embodiment, the wire mesh structureis comprised of a metal. In one embodiment, the metal is a shape memorymetal, such as Nitinol. In various embodiments, the metal wire comprises50% or less of the surface area of the wire mesh structure. Theremaining surface area of the wire mesh structure comprises the openingsbetween the wires. The openings in the mesh structure could optionallybe covered partially or completely with a membrane. The membrane alongwith wire-mesh structure could form a valve mechanism that controls therate or directionality of flow. In various embodiments, the wire meshstructure has a post-deployment diameter that is greater than thediameter of an open pylorus. In various embodiments, the wire meshstructure is fabricated via automated braiding, non-automated braiding,laser cutting, tube cutting, or fixed or variable rigidity plateforming.

In one embodiment, in the post-deployment configuration, the wire meshstructure has a spherical shape. In various embodiments, the sphericalwire mesh structure has a diameter in a range of 5 cm to 25 cm. In oneembodiment, the spherical wire mesh structure has a diameter of 15 cm.In another embodiment, in the post-deployment configuration, the wiremesh structure has an oval shape. In various embodiments, the oval wiremesh structure has a diameter at its midpoint in a range of 1 cm to 20cm and length from its proximal end to its distal end in a range of 5 cmto 25 cm. In one embodiment, the oval wire mesh structure has a diameterat its midpoint of 10 cm and a length from its proximal end to itsdistal end of 15 cm. In another embodiment, in the post-deploymentconfiguration, the wire mesh structure has an ovoid shape. In anotherembodiment, in the post-deployment configuration, the wire meshstructure has a football shape. In various embodiments, the footballshaped wire mesh structure has a diameter at its midpoint in a range of5 cm to 25 cm and length from its proximal end to its distal end in arange of 10 cm to 25 cm. In one embodiment, the football shaped wiremesh structure has a diameter at its midpoint of 10 cm and a length fromits proximal end to its distal end of 20 cm. In another embodiment, themesh device has a dumbbell shape. The dumbbell shape could be primarilywoven as such or can be created by coupling two spherical, oval or anyother of the above shaped devices. In various other embodiments, in thepost-deployment configuration, the wire mesh structure has a shape thatapproximates the shape of a normal or surgically altered stomach. In oneembodiment, in the post-deployment configuration, the shape of thewire-mesh structure could be customized to the shape, size or volume ofan individual stomach. In another embodiment, the size or volume of thewire-mesh structure depends upon the magnitude of the desired weightloss. Those skilled in the art would recognize the wire mesh structurecan take on any number of post-deployment shapes that would enable thedevice to have a space occupying effect and prevent it from being passedcompletely through the pylorus. In one embodiment, the wire meshstructure has a width at its midpoint that is less than its length fromits proximal end to its distal end. In another embodiment, the wire meshstructure has a width at its midpoint that is equal to its length fromits proximal end to its distal end. In another embodiment, the wire meshstructure has a width at its midpoint that is greater than its lengthfrom its proximal end to its distal end.

In various embodiments, the wire mesh structure includes at least onefirst opening proximate its proximal end and at least one second openingproximate its distal end. In various embodiments, the first opening atthe proximal end is 50 mm or less in diameter and the second opening atthe distal end is 100 mm or less in diameter. The first opening at theproximal end of the wire mesh structure is in fluid communication withthe internal volume of the wire mesh structure which, in turn, is influid communication with the second opening at the distal end of thewire mesh structure. The first opening proximate the proximal end is forthe entrance of food into the wire mesh structure and the second openingproximate the distal end is for the exit of food from the wire meshstructure. In some embodiments, the first opening or total area ofmultiple first openings proximate the proximal end of the wire meshstructure is smaller than the second opening or total area of multiplesecond openings proximate the distal end of the wire mesh structure. Inother embodiments, the first opening or total area of multiple firstopenings proximate the proximal end of the wire mesh structure is equalin size to the second opening or total area of multiple second openingsproximate the distal end of the wire mesh structure. In otherembodiments, the first opening or total area of multiple first openingsproximate the proximal end of the wire mesh structure is larger than thesecond opening or total area of multiple second openings proximate thedistal end of the wire mesh structure. The wire mesh also includesopenings between the wires of its mesh weave. These openings, while alsoallowing the passage of food into and out of the device, aresubstantially smaller than those positioned at either the proximal orthe distal ends of the wire mesh structure or both.

In various embodiments, the wire mesh structure comprises different wiremesh weave patterns that impart particular performance characteristicsto the device. For example, in one embodiment, the wire mesh structurecomprises a weave pattern that provides the wire mesh with a consistentradial strength throughout, wherein said radial strength resists thecompressive force of the stomach. The radial strength of the wire meshstructure prevents it from being compressed completely or permanently bythe contractions of the stomach and passed through the pylorus. Inanother embodiment, the wire mesh structure comprises a weave patterndesigned to make the wire mesh more easily compressible along itshorizontal axis than along its vertical axis. In another embodiment, thewire mesh structure comprises a weave pattern designed to make the wiremesh more easily compressible along its vertical axis than along itshorizontal axis. The wire mesh structure includes a midpoint defining anupper portion and a lower portion (for example, in an embodiment whereinthe wire mesh structure has a spherical shape, it includes an equatorwith an upper hemisphere and a lower hemisphere). In one embodiment, theupper and lower portions comprise different wire mesh weave patternssuch that the upper portion has a greater radial strength as provided byits wire mesh weave pattern than the radial strength provided to thelower portion by its wire mesh weave pattern. In this embodiment, forcesfrom the contractions of the stomach antrum are transmitted through theweaker lower portion of the wire mesh structure to help move the foodthrough the device. In another embodiment, the upper portion of thedevice comprises a wire mesh weave and the lower portion comprises onlya flexible membrane. This membrane is pliable enough to allow forcesfrom stomach contractions to pass through and help move food through thedevice.

In another embodiment, the wire mesh structure includes a mechanism forfixing the wire mesh structure in its expanded configuration so itcannot be completely or permanently compressed by gastric contractions.In various embodiments, the mechanism comprises a rod, radial spokes, ordisc within the wire mesh structure. In one embodiment, the mechanismcomprises a separate device or structure having a radial strengthgreater than that of the wire mesh structure. The mechanism is notengaged while the device is in the compressed configuration. Afterdelivery, a physician uses a working tool of an endoscope to fix themechanism in place. When the device is ready to be removed, thephysician disengages the mechanism so the device can be returned to itscompressed configuration for retrieval.

Most wire mesh structures elongate when they are compressed. Preventingthe elongation of the device will prevent accidental or unplannedcompression of the device and hence prevent inadvertent passage ormigration from its desired location. In one embodiment, a structure canbe engaged post-deployment that prevents elongation of the device. Thestructure can be disengaged at the time of removal allowing for thedevice to be compressed. The structure could be a wire structure, aplastic structure, or a polymer or silk structure which connects theproximal and distal ends of the device and prevents the device fromelongating while the structure is engaged.

In another embodiment, the metal wire of the wire mesh structure istemperature sensitive. While in the gastric environment and exposed tobody temperature, the metal wire has a greater strength and the wiremesh structure in non-compressible. In one embodiment, for delivery, acooling element is applied to the wire mesh structure. As the wire iscooled, the wire mesh structure remains in a more compressed shape as acoaxial covering sheath or constricting thread is removed, facilitatingwithdrawal of a delivery device. In one embodiment, for removal, acooling element is applied to the wire mesh structure. As the wire iscooled, the wire mesh structure becomes more malleable and can be easilyconstricted to its compressed configuration for retrieval.

In various embodiments, the wire mesh structure further includes amembrane covering at least a portion of the wire mesh. The membrane isdesigned to be flexible and move with the wire mesh as it transfiguresbetween its various configurations. In one embodiment, the membrane doesnot cover the first or second openings of the wire mesh structure. Inone embodiment, the membrane is substantially nonporous and prevents thepassage of food through any openings in the wire mesh structure overwhich the membrane is positioned. In another embodiment, the membranehas some level of porosity and allows small amounts of chyme to passthrough. In one embodiment, the membrane includes at least one openingpositioned to align directly with at least one opening between the wiresof the wire mesh structure. In one embodiment, the membrane with thewire mesh structure forms at least one valve or flap corresponding tosaid at least one opening. In one embodiment, the valve or flap isunidirectional and allows food to enter the device but not exit thedevice. In another embodiment, the valve controls the rate of flow.

The gastric fundus is involved in the release of various gut hormonessuch as “hunger hormones” ghrelin, orexin and pancreatic peptide 3-36(PYY 3-36), and “satiety hormones”, e.g., leptin, obestatin, andnesfatin-1. The release of these hormones is mediated by contact of thegastric mucosa with various nutrients in the ingested food. The wiremesh structure will prevent sequestered food from coming into contactwith the gastric cardia and fundus or reduce its contact time. This willresult in physiological exclusion of the gastric cardia and fundus, amechanism thought to play a role in satiety and weight loss and is oneof the mechanisms in play in RGB gastric bypass surgery. In oneembodiment, the wire mesh structure sequesters food within its internalvolume for no more than 24 hours.

The wire mesh structure freely floats in the gastric cavity withoutexerting constant force at a singular point for a prolonged period. Oneor more portions of the wire-mesh structure can temporarily put pressureor create stretch or distension of one or more portions of the stomachto create a desirable therapeutic effect. The top of the mesh structurecould press on the gastric cardia or fundus, thus generating a feelingof fullness or satiety, decreasing caloric intake or inducing weightloss or glycemic control. The lower portion of the device is designed totemporarily and intermittently engage the distal body or the antrum ofthe stomach to create stretch or distension to create a desirabletherapeutic effect. Additionally this may create intermittentobstruction and/or delay the passage of food from the stomach into theintestine.

Sleeve

In various embodiments, the intragastric device of the presentspecification further comprises a flexible sleeve component coupled tothe wire mesh structure. In multiple embodiments, any of the wire meshstructures discussed above is coupled with any of the sleeve componentsdiscussed below. The sleeve component comprises an elongate tubular bodyhaving a proximal end and a distal end a lumen within. In variousembodiments, the sleeve has a length within a range of 6 inches to 120inches. In one embodiment, the sleeve has a length of 24 inches. Inanother embodiment, the sleeve has a length of 30 inches. In oneembodiment, the sleeve could be functionally made out of multiplesleeves wherein the cumulative length of the sleeves in combination isgreater than 6 inches. In various embodiments, the sleeve has a diameterwithin a range of 1 cm to 10 cm. In one embodiment, the sleeve has adiameter of 5 cm. In another embodiment the sleeve has a diameter of 3cm. The proximal end of the sleeve body includes a first opening forpassage of food from the wire mesh structure into the sleeve. In oneembodiment, the sleeve component comprises a second opening at thedistal end of the sleeve body for the exit of food into the smallintestine. In another embodiment, the sleeve component comprises asecond opening along the length of the sleeve body proximate its distalend for the exit of food into the small intestine. The first opening atthe proximal end of the sleeve body is in fluid communication with thelumen of the sleeve body which, in turn, is in fluid communication withthe second opening at the distal end of the sleeve body. In variousembodiments, the first and second openings of the sleeve each have adiameter that is less than, equal to or greater than the diameter of theduodenum. In one embodiment, a portion of the wire-mesh structure canintermittently engage the pylorus or pass through the pylorus. Thesleeve component is designed to extend distally from the distal end ofthe wire mesh structure. The wire mesh structure resides in the stomachof the patient, just proximal to the pylorus. In various embodiments,the sleeve component passes through the pylorus and into the duodenum orproximal portion of the jejunum, where it remains during deployment.Food enters the proximal end of the wire mesh structure, passes throughthe wire mesh structure, into the sleeve component, through the sleevecomponent, and out into the small intestine through the distal end ofthe sleeve. As such, food bypasses the very distal end of the stomach,the pylorus, the duodenum (and therefore ampulla of vater), andoptionally the proximal portion of the jejunum. The sleeve thereforeacts to bypass portions of the GI tract in order to limit the absorptionof specific materials in the intestine. The benefits provided by asleeve are similar to those provided by Roux-en-Y gastric bypasssurgery, namely, weight loss and improvement of type II diabetes.

In one embodiment, the proximal end of the sleeve body is coupleddirectly to the wire mesh structure at any position on the lower portionof said wire mesh structure such that the sleeve component covers thesecond opening at the distal end of the wire mesh structure and thesecond opening of the wire mesh structure is in fluid communication withthe first opening of the proximal end of the sleeve body. In anotherembodiment, the device includes an additional wire mesh junctionconnecting the wire mesh structure to the sleeve component. In anotherembodiment, the sleeve component is tethered to the wire mesh structureby two or more connecting elements such that the first opening at theproximal end of the sleeve body is spaced apart from the second openingat the distal end of the wire mesh structure. This embodiment isdesigned to capture food in the sleeve that does not enter and exitthrough the wire mesh structure. In yet another embodiment, a firstsleeve component is coupled directly to the lower portion of the wiremesh structure and a second sleeve component is tethered to the wiremesh structure at a distance spaced apart from said wire mesh structureas discussed above. In another embodiment the second sleeve is coupledto the first sleeve. This embodiment is designed to allow for thecapture of both food passing through the wire mesh structure and foodpassing around the wire mesh structure.

In various embodiments, multiple sleeves can be added to the end of themost distal existing sleeve, continually elongating the device andresulting in multiple telescoping sleeves.

In various embodiments, the sleeve is glued, sutured, or thermally fusedto the wire mesh structure. In one embodiment, the sleeve comprises amesh having a radial force that pushes the sleeve onto the wire meshstructure and thereby secures said sleeve to said wire mesh structure.

The distal end of the sleeve can be designed to be weighted so that thesleeve remains in an elongated shape extending through a portion of theduodenum. In one embodiment, the sleeve includes a small weight attachedto its distal end. In another embodiment, wherein the second opening atthe distal end of the sleeve body is positioned along the sleeve body atits distal end, the distal end of the sleeve body further includes ablind pouch. The blind pouch functions to intermittently trap a smallportion of food or fluid there within. The trapped food or fluid acts toweigh down the distal end of the sleeve body, thereby keeping the sleevecomponent elongated.

In one embodiment, the sleeve component comprises a mesh that isflexible and compressible by the contractions of the small intestine.The mesh weave pattern of the sleeve component is different than that ofthe three dimensional wire mesh structure in that it has a lower radialstrength, allowing the sleeve component to be compressed by the duodenumwherein the compression helps food progress along the sleeve length.Although the mesh weave pattern of the sleeve component allows thesleeve to be compressed by intestinal contractions, it is strong enoughto provide structural support to the sleeve body and maintain the sleevein an elongated shape, preventing permanent bending, twisting or kinkingof the sleeve which may lead to sleeve obstruction.

In one embodiment, the sleeve comprises a differential mesh structurewherein the sleeve has a greater radial strength proximally and lessradial force distally to provide less buckling proximally and allow formore flexibility distally.

In one embodiment, the sleeve includes at least one component comprisedof a bio-absorbable material and at least one component comprised of anon-bio-absorbable material. The components comprising anon-bio-absorbable material comprise the proximal portion of the sleeveand the components comprising a bio-absorbable material comprise thedistal portion of the sleeve. As the distal components are absorbed bythe human body, the sleeve shortens in length. In another embodiment thesleeve is made of multiple non-bio-absorbable components connected bybio-absorbable components. The bio-absorbable components dissolve overtime resulting in planned disassembly of the sleeve and spontaneouspassage of the components through the gastrointestinal tract.

In one embodiment, the sleeve is made of a biocompatible fabric such asa Dacron mesh. The fabric mesh could serve as a scaffolding for growthand colonization by microbiota that promote weight loss. Such microbiotacould be applied before insertion of such a device or administered asprobiotics to the patient. Other therapeutic agents could be combinedwith the device to enhance the therapeutic effect of the device.

In another embodiment, the sleeve component comprises a membrane that isflexible and compressible by the contractions of the small intestine. Inone embodiment, the membranous sleeve component comprises a plurality ofhorizontal and/or vertical support elements along the length of thesleeve body. In one embodiment, the horizontal elements include wirerings spaced apart along the length of the sleeve body. In variousembodiments, the rings are spaced between 2 and 24 inches apart. In oneembodiment, the rings are spaced 6 inches apart. In one embodiment, thevertical support elements include elongate metal wires. In variousembodiments, the wires are between 2 and 60 inches in length. In oneembodiment, the metal wires are 6 inches in length. In anotherembodiment, the membranous sleeve component comprises a spiral metalwire extending along its length. The spiral metal wire provides supportto the sleeve component and maintains its elongated shape. In variousembodiments, the membrane of the sleeve component extends proximallyonto the lower portion of the wire mesh structure and covers all or aportion of said lower portion.

The sleeve is flexible and compressible such that during delivery it isrestrained in a compressed configuration on the distal end of a deliverydevice. In one embodiment, the sleeve telescopes into itself to shortenits length and facilitate delivery.

In one embodiment, the wire mesh structure and sleeve are deliveredseparately and assembled within a patient's gastrointestinal tract. Thewire mesh structure is delivered into the stomach of a patient by afirst catheter and then the sleeve is delivered into the wire meshstructure by a second catheter. The distal end of the sleeve is extendedthrough the distal opening in the wire mesh structure and then theproximal end of the sleeve is coupled to said distal end of the wiremesh structure.

In one embodiment, a first small wire mesh structure with coupled sleeveis implanted into a patient. Later, if desired, a second, larger wiremesh structure can be deployed around the first small wire meshstructure to increase device efficacy.

In various embodiments, the sleeve includes one or more radiopaquemarkers to ensure proper positioning of the sleeve using radiographicimaging.

In various embodiments, 1-99% of ingested food passes through thesleeve. In one embodiment, more than 25% of the ingested food passesthrough the sleeve. In another embodiment, more than 10% of the ingestedfood passes through the sleeve.

Retrieval Mechanism

In various embodiments, the wire mesh structure or wire mesh structurewith coupled sleeve component includes one or more retrieval mechanismswith at least one retrieval mechanism positioned proximate the at leastone opening at the proximal end of the wire mesh structure. In oneembodiment, the retrieval mechanism is formed from an extension of thewire mesh comprising the wire mesh structure. In another embodiment, theretrieval mechanism is a separate piece of wire or thread or tie that isfixedly attached to the wire mesh structure. The retrieval mechanismcomprises an engaging mechanism such as a loop that, in variousembodiments, can be engaged by a hook or grasper from a retrievalinstrument. A physician can use a retrieval instrument to engage theretrieval mechanism of the deployed intragastric device to compress theintragastric device to withdraw the device from a patient's body. Theretrieval mechanism can be included on any of the wire mesh structure,wire mesh structure with sleeve, or wire mesh structure with sleeve andanti-migration component embodiments (as discussed below) of the presentspecification.

Anti-Migration Component

In various embodiments, the wire mesh structure or wire mesh structurewith coupled sleeve component includes one or more anti-migrationcomponents. In one embodiment, the anti-migration component is comprisedof a metal. In one embodiment, the metal is a shape memory metal, suchas Nitinol. The anti-migration component is preferably positioned at thedistal end of the wire mesh structure (at the junction of the wire meshstructure with the sleeve component in the embodiment of the deviceincluding a sleeve) and, once the device is deployed, comes to restproximal to the pylorus. The anti-migration component functions toprevent passage of the wire mesh structure or entire device through thepylorus. In one embodiment, the anti-migration component is compressedalong with the wire mesh structure when the device is in its firstconfiguration. Once deployed, in one embodiment, the anti-migrationcomponent has a width that is greater than that of the wire meshstructure, preventing passage through the pylorus. In anotherembodiment, the anti-migration component comprises a wire weave patternhaving a radial strength sufficient to resist the compressive force ofthe stomach, preventing complete or permanent constriction of theanti-migration component by stomach contractions and subsequentmigration of the device through the pylorus.

In one embodiment, in the post-deployment configuration, theanti-migration component has a distally sloping disc shape. In anotherembodiment, in the post-deployment configuration, the anti-migrationcomponent has a proximally sloping disc shape. In another embodiment, inthe post-deployment configuration, the anti-migration component has aflat disc shape. In another embodiment, the disc can assume any of thesethree disc shapes depending on the position of the device in thestomach. In another embodiment, in the post-deployment configuration,the anti-migration component has a half-bumper shape. In anotherembodiment, in the post-deployment configuration, the anti-migrationcomponent has a full bumper shape. Those skilled in the art wouldrecognize, in the post-deployment configuration, the anti-migrationcomponent can take on any number of shapes that would prevent the devicefrom being passed completely through the pylorus.

In various embodiments, various components of the device, including thewire mesh structure, retrieval mechanism, and/or anti-migrationcomponent are made of or coated with a corrosion-resistant material toprevent damage to the device upon exposure to gastrointestinal contents.In one embodiment, the material is silicone. In another embodiment, thematerial is polyester. In another embodiment the material is a medicalgrade epoxy or Parylene. In another embodiment, the material is PEEK. Inanother embodiment, the material is carbon fiber. In another embodiment,the material is ceramic. In another embodiment, the material is anadditional metal. In one embodiment, the coating metal is tantalum.Tantalum provides corrosive resistance and radiopacity. In oneembodiment, wherein the coating is ceramic, the ceramic coating has athickness of several angstrom. In various embodiments, any one orcombination of the above corrosive resistant materials is used to coatthe device components.

In various embodiments, the wire mesh structure of the intragastricdevice includes one or more circumferential constricting mechanisms usedto constrict the wire mesh structure, returning it to its compressedconfiguration for retrieval. In one embodiment the constrictingmechanism is a zip-tie. In another embodiment, the constrictingmechanism is a twist-tie. In various embodiments the circumferentialconstricting mechanism has additional mechanisms to keep the wire meshstructure in the constricted position without the need for applicationof constant force by the operator. In one embodiment, the additionalmechanism is a crimp or a clamp.

In various embodiments, the wire mesh structure, hook, and/oranti-migration component include a radiopaque marker for radiographicvisualization to facilitate delivery and retrieval.

In various embodiments, the intragastric device of the presentspecification further includes at least one sensor. In one embodiment,the sensor is a flow or impedance sensor and measures the amount of foodpassing through and/or around the device. In one embodiment, the sensoris a glucose sensor and measures the quality and/or quantity of foodpassing through and/or around the device. In another embodiment, thesensor is a temperature sensor. In another embodiment, the sensor is anaccelerometer. In another embodiment, the sensor is a pH sensor.

It should be appreciated that any combination of one or more of any theembodiments of the wire mesh structure, sleeve, retrieval mechanism, andanti-migration component disclosed in the present specification can beused to create an intragastric device.

Delivery Device

The present specification also discloses various embodiments of adelivery device used to deploy an intragastric device in thegastrointestinal tract of a patient. In various embodiments, theproximal portion of the delivery device is less flexible than the distalportion to allow for deployment of the wire mesh structure in thestomach and deployment of the sleeve in the more tortuous smallintestine. The variable flexibility is achieved by the delivery catheteralone or the combination of the delivery catheter and the intragastricdevice loaded onto that catheter. In various embodiments, the mostdistal portion of the delivery device comprises a material that is moreflexible than the more proximal distal portion of the device. In otherembodiments, the most distal portion of the delivery device has asmaller diameter than the more proximal distal portion of the device,imparting greater flexibility to the most distal portion relative tosaid more proximal distal portion. In various embodiments, the variableflexibility is achieved by the combination of the delivery catheter andthe device. In various embodiments, the delivery device comprises anelongate body having a proximal end and a distal end and includes asuture or thread to constrict the intragastric device, ports to accesssaid suture or thread, and/or a locking mechanism to lock the deliverydevice. In one embodiment the delivery device has a lumen for passageover a guidewire. In one embodiment, the most distal portion has aspherical shape to end to help track the catheter over a guidewire. Invarious embodiments, the delivery device includes a shrink wrappedcoaxial sheath that slides over the compressed intragastric device andunzips or tears away to allow for delivery. In one embodiment, thedelivery device includes a first sheath covering the wire mesh structureand a second sheath covering the sleeve. The second sheath has a smallerdiameter and is removed from the sleeve by pulling the second sheaththrough the openings in the wire mesh structure. In one embodiment, thedelivery device includes two handles for deploying the wire meshstructure and sleeve separately. In one embodiment, the delivery deviceincludes distinct segments of suture material constraining varioussegments of the device. In another embodiment, there are two or moremechanisms employed and operated separately to deploy various componentsof the device.

Retrieval Device

The present specification also discloses various embodiments of aretrieval device used to remove an intragastric device from thegastrointestinal tract of a patient. In various embodiments, theretrieval device comprises an elongate body having a proximal end, adistal end and includes a wire, a grasping hook, a grasper, an actuator,a handle, and/or at least one clamp.

Assembly of Device Components Inside the Human Body

In one embodiment, various components of the device come pre-assembledfrom the manufacturer. In another embodiment, the various components ofthe device are assembled pre-procedure or intra-procedure by theoperator. In one embodiment, the wire-mesh structure and the sleeve aresupplied as two separate device components. The operators deploy the twocomponents separately and intra-procedure couple the sleeve with thewire-mesh structure. The optional anti-migration structure could be aportion of the mesh, sleeve or could be supplied separately as a thirdstructure. Additionally, one or more mesh structures or one or moresleeve structures could be coupled for enhanced therapeutic benefit.

The present invention is directed towards multiple embodiments. Thefollowing disclosure is provided in order to enable a person havingordinary skill in the art to practice the invention. Language used inthis specification should not be interpreted as a general disavowal ofany one specific embodiment or used to limit the claims beyond themeaning of the terms used therein. The general principles defined hereinmay be applied to other embodiments and applications without departingfrom the spirit and scope of the invention. Also, the terminology andphraseology used is for the purpose of describing exemplary embodimentsand should not be considered limiting. Thus, the present invention is tobe accorded the widest scope encompassing numerous alternatives,modifications and equivalents consistent with the principles andfeatures disclosed. For purpose of clarity, details relating totechnical material that is known in the technical fields related to theinvention have not been described in detail so as not to unnecessarilyobscure the present invention.

FIG. 1 is an illustration of an upper gastrointestinal system. Afterswallowing, food passes rapidly through the esophagus 111 into thestomach 112. There, it is digested for a period of time and undergoesthe process of dilution to an iso-osmotic concentration by grinding andmixing with gastric juices. The stomach 112 relaxes to accommodate thevolume of ingested food. As the stomach 112 gets filled with food thesensation of fullness or satiety is generated by stretch receptors inthe gastric wall and the person stops eating. The iso-osmotic food,known as chyme, then passes through the pylorus 113 into the duodenum114. Passage of chyme into the duodenum 114 results in the release ofenzyme rich pancreatic secretions from the pancreas 115 and bile saltrich biliary secretions from the liver 116. The biliary secretionstravel through the common bile duct 117 where they combine with thepancreatic secretions arriving through the pancreatic duct 118 and thetwo ducts combine to form the ampulla of vater 119. The ampulla of vater119 serves as the entry point for the secretions to be deposited intothe duodenum 114. In the jejunum 120, the mixing of pancreatic andbiliary secretions with the chyme results in the digestion of proteins,fats, and carbohydrates, which are then absorbed into the blood stream.

FIG. 2A is an illustration of a wire mesh structure 201 of anintragastric device 200 a in a post-deployment configuration inaccordance with one embodiment of the present specification, depicting afirst weave pattern. The weave pattern is substantially uniformthroughout the entire structure 201. The wire mesh structure 201includes a proximal end and a distal end and defines an internal volume.The wire mesh structure 201 has a length l extending from its proximalend to its distal end and a width w extending horizontally across itsmidpoint. In the pictured embodiment, the length l is greater than thewidth w. The proximal end of the wire mesh structure 201 includes afirst opening 210 and the distal end of the wire mesh structure 201includes a second opening 215 that is larger than the first opening 210.The wire mesh structure 201 helps to treat obesity by occupying anddisplacing a volume of space in a patient's stomach, thereby decreasingthe amount of food the patient can eat before experiencing a feeling ofsatiety. In one embodiment, the wire mesh structure displaces no lessthan 10% of the volume of a patient's stomach. Optionally, the wire meshstructure 201 also helps to treat obesity by slowing the passage of foodin the gastrointestinal (GI) tract. Food enters the device 200 a at thefirst opening 210, passes through the internal volume of the wire meshstructure 201, and then passes out of the device 200 a through thesecond opening 215. Food captured by the device 200 a is sequesteredwithin the wire mesh structure 201 for a period of time, therebydelaying gastric emptying and prolonging a patient's feeling of satiety.

FIG. 2B is an illustration of a wire mesh structure 202 of anintragastric device 200 b in a post-deployment configuration inaccordance with another embodiment of the present specification,depicting a second weave pattern. The wire mesh structure 202 includes aproximal end and a distal end and defines an internal volume. The wiremesh structure 202 has a length l extending from its proximal end to itsdistal end and a width w extending horizontally across its midpoint. Inthe pictured embodiment, the length l is greater than the width w. Thewire mesh structure 202 comprises an upper portion 221 and a lowerportion 222. The weave patterns of the two portions 221, 222 aresubstantially identical. In addition, the wire mesh structure 202comprises a proximal wire mesh header 223 at the top of the upperportion 221. In one embodiment, the proximal wire mesh header 223 has aweave pattern that is different than the weave pattern of the upperportion 221 and lower portion 222. In one embodiment, the proximal wiremesh header 223 comprises a wire that is an extension of the wirecomprising the upper portion 221. In another embodiment, the proximalwire mesh header 223 comprises a separate wire that is fixedly attachedto the upper portion 221. The proximal wire mesh header 223 has a firstopening 220 at its proximal end. The wire mesh structure 202 has asecond opening 225 at its distal end that is smaller than the firstopening 220. Food enters the device 200 b at the first opening 220,passes through the internal volume of the wire mesh structure 202, andthen passes out of the device 200 b through the second opening 225.

FIG. 2C is an illustration of a wire mesh structure 203 of anintragastric device in a post-deployment configuration in accordancewith another embodiment of the present specification, depicting a thirdweave pattern. The wire mesh structure 203 includes a proximal end and adistal end and defines an internal volume. The wire mesh structure 203has a length l extending from its proximal end to its distal end and awidth w extending horizontally across its midpoint. In the picturedembodiment, the length l is greater than the width w. The wire meshstructure 203 comprises an upper portion 231 and a lower portion 232.The weave patterns of the two portions 231, 232 are substantiallyidentical. In addition, the wire mesh structure 203 comprises a proximalwire mesh header 233 at the top of the upper portion 231 and a distalwire mesh footer 234 at the bottom of the lower portion 232. In oneembodiment, the proximal wire mesh header 233 has a weave pattern thatis different than the weave pattern of the upper portion 231 and lowerportion 232. In one embodiment, the proximal wire mesh header 233comprises a wire that is an extension of the wire comprising the upperportion 231. In another embodiment, the proximal wire mesh header 233comprises a separate wire that is fixedly attached to the upper portion231. In one embodiment, the distal wire mesh footer 234 has a weavepattern that is different than the weave pattern of the upper portion231 and lower portion 232. In one embodiment, the distal wire meshfooter 234 comprises a wire that is an extension of the wire comprisingthe lower portion 232. In another embodiment, the distal wire meshfooter 234 comprises a separate wire that is fixedly attached to thelower portion 232. The proximal wire mesh header 233 has a first opening230 at its proximal end and the distal wire mesh footer 234 has a secondopening 235 at its distal end. The second opening 235 is smaller thanthe first opening 230. Food enters the device 200 c at the first opening230, passes through the internal volume of the wire mesh structure 203,and then passes out of the device 200 c through the second opening 235.

The wire mesh structures of FIGS. 2A through 2C are all configurablebetween a first, compressed configuration (as seen in FIG. 52 ) tofacilitate delivery and removal and a second expanded configuration (asseen in FIGS. 2A through 2C) once deployed. The wire mesh structuresdepicted in FIGS. 2A through 2C are all more easily compressible alongthe vertical axis.

FIG. 2D is an illustration of a wire mesh structure 204 of anintragastric device 200 d in a post-deployment configuration inaccordance with another embodiment of the present specification,depicting a fourth weave pattern. The wire mesh structure 204 includes aproximal end and a distal end and defines an internal volume. The wiremesh structure 204 has a length l extending from its proximal end to itsdistal end and a width w extending horizontally across its midpoint. Theweave pattern of the wire mesh structure 204 depicted in FIG. 2D issubstantially similar to the weave pattern of the wire mesh structure202 depicted in FIG. 2B. However, referring to FIG. 2D, the length l ofthe wire mesh structure 204 is less than the width w. The wire meshstructure 204 comprises an upper portion 241 and a lower portion 242.The weave patterns of the two portions 241, 242 are substantiallyidentical. In addition, the wire mesh structure 204 comprises a proximalwire mesh header 243 at the top of the upper portion 241. The proximalwire mesh header 243 has a first opening 240 at its proximal end. Thewire mesh structure 204 has a second opening 245 at its distal end. Foodenters the device 200 d at the first opening 240, passes through theinternal volume of the wire mesh structure 204, and then passes out ofthe device 200 d through the second opening 245.

FIG. 2E is an illustration of a wire mesh structure 205 of anintragastric device 200 e in a post-deployment configuration inaccordance with yet another embodiment of the present specification,depicting a fifth weave pattern. The wire mesh structure 205 includes aproximal end and a distal end and defines an internal volume. The wiremesh structure 205 has a length l extending from its proximal end to itsdistal end and a width w extending horizontally across its midpoint. Theweave pattern of the wire mesh structure 205 depicted in FIG. 2E issubstantially similar to a 90 degree rotation of the weave pattern ofthe wire mesh structure 202 depicted in FIG. 2B. Referring to FIG. 2E,the length l of the wire mesh structure 205 is less than the width w.The wire mesh structure 205 comprises an upper portion 251 and a lowerportion 252. The weave patterns of the two portions 251, 252 aresubstantially identical. In addition, the wire mesh structure 205comprises a proximal wire mesh header 253 at the top of the upperportion 251. The proximal wire mesh header 253 has a first opening 250at its proximal end. The wire mesh structure 205 has a second opening255 at its distal end. Food enters the device 200 e at the first opening250, passes through the internal volume of the wire mesh structure 205,and then passes out of the device 200 e through the second opening 255.

The wire mesh structures of FIGS. 2D and 2E are both configurablebetween a first, compressed configuration to facilitate delivery andremoval and a second expanded configuration (as seen in FIGS. 2D and 2E)once deployed. The wire mesh structures depicted in FIGS. 2D and 2E areall more easily compressible along the horizontal axis. As such, it willbe more difficult for gastric contractions to compress the wire meshstructures vertically. Vertical compression would make the devicethinner along its length, allowing it to be more easily passed throughthe pylorus. Therefore, the shape of the wire mesh structures depictedin FIGS. 2D and 2E provides an additional benefit of immovabilityrelative to a patient's pylorus.

FIG. 2F is an illustration of another embodiment of a wire meshstructure 206 of an intragastric device 200 f in an exemplarypost-deployment configuration. The device 200 f comprises an oval shapedwire mesh structure 206 and includes a first opening 260 at its proximalend and a second, larger opening 265 at its distal end. In variousembodiments, the wire mesh of the device 200 f is coated with acorrosion resistant material to prevent damage to the wire mesh of thedevice 200 f by gastric contents. The device 200 f further includes, atits distal end, an anti-migration component 269 to prevent migration ofthe device 200 f past the pylorus. In various embodiments, the diameterof the anti-migration component 269 is greater than the diameter of thepylorus when fully relaxed. As such, the anti-migration component 269functions as a physical barrier to prevent passage of the device throughthe pylorus. In the pictured embodiment, the anti-migration component269 comprises a distal extension of the wire mesh from the distal end ofthe device 200 f The wire mesh extension curls outwardly and thenextends back a short distance proximally, forming a rounded bumpershaped anti-migration component 269. In various embodiments (not shown),the anti-migration component can have a disc shape, saucer shape, or anyother shape which will help prevent passage of the device through thepylorus. In various embodiments, the anti-migration component can be anextension of the wire mesh (as pictured) or can be a separate piece ofwire mesh (not shown) that is attached to the distal end of the wiremesh structure of the device. In one embodiment, the wires of the device200 f, including the wires of the anti-migration component 269, arecovered in a corrosion-resistant material. In one embodiment, thematerial is silicone. In another embodiment, the material is parylene.

FIG. 2G is an illustration of yet another embodiment of a wire meshstructure 207 of an intragastric device 200 g in an exemplarypost-deployment configuration and FIG. 2H is a cross-sectionalillustration of the embodiment of the intragastric device depicted inFIG. 2G. Referring to FIGS. 2G and 2H simultaneously, the device 200 g,200 h comprises a wire mesh structure covered 207, 208 by a membrane277, 287 about its entire outer surface with the exception of a firstopening 270, 280 at its proximal end and a second, larger opening 275,285 at its distal end. The device 200 g, 200 h also includes ananti-migration component 279, 289 at its distal end. Similar to thedevice shown in FIG. 2F, the anti-migration component 279, 289approximates a bumper shape and is formed from an extension of the wiremesh structure extending distally and then curling outward and extendingback a short distance proximally. The curved shape of the anti-migrationcomponent 279, 289 is well visualized in the cross-sectionalillustration of FIG. 2H.

FIG. 2I is an illustration of another embodiment of a wire meshstructure of an intragastric device 200 i in an exemplary pre-deploymentconfiguration. The pre-deployment configuration takes a compressed,cylindrical shape to facilitate insertion.

FIG. 2J is an illustration of the intragastric device 200 j of FIG. 2Iin an exemplary post-deployment configuration. The post-deploymentconfiguration takes an expanded, spiral wire shape to occupy gastricvolume and permit the sequestering of food within the device. In oneembodiment, the spiral structure is covered with a membrane 278containing openings of the same or different sizes. In one embodiment,the openings have valves to direct the flow of food preferentially in aninward or an outward direction.

FIG. 2K is an illustration of yet another embodiment of a wire meshstructure of an intragastric device 200 k in an exemplary pre-deploymentconfiguration. The pre-deployment configuration takes a compressed,cylindrical shape to facilitate insertion.

FIG. 2L is an illustration of the intragastric device 2001 of FIG. 2K inan exemplary post-deployment configuration. The post-deploymentconfiguration takes an expanded, spiral strip shape, similar to anorange peel, to occupy gastric volume and permit the sequestering offood within the device. In one embodiment, the spiral structure iscovered with a membrane 281 containing openings of the same or differentsizes. In one embodiment, the openings have valves to direct the flow offood preferentially in an inward or an outward direction.

FIG. 2M is an illustration of yet another embodiment of a wire meshstructure of an intragastric device 200 m in an exemplary pre-deploymentconfiguration. The pre-deployment configuration takes a compressed,cylindrical shape to facilitate insertion.

FIG. 2N is an illustration of the intragastric device 200 n of FIG. 2Min an exemplary post-deployment configuration. The post-deploymentconfiguration takes an expanded, wire mesh shape to occupy gastricvolume and permit the sequestering of food within the device. In oneembodiment, the wire mesh structure is covered with a membrane 283containing openings of the same or different sizes. In one embodiment,the openings have valves to direct the flow of food preferentially in aninward or an outward direction.

FIG. 2O is an illustration of one embodiment depicting an exemplarypost-deployment, membrane 284 covered intragastric device 200 o withvarying sized openings along its surface. The middle two-thirds of thedevice 200 o contain larger holes 286 and the top and bottom one-thirdcontain smaller holes 288. In one embodiment, the larger holes 286 havevalves composed of the same membranous material to direct the flow offood preferentially into the device 200 o. Thereafter, food slowly exitsthe device 200 o through the smaller holes 288 positioned at the top andbottom of the device 200 o, thereby delaying gastric emptying.

FIG. 2P is an illustration of another embodiment of an intragastricdevice 200 p in an exemplary post-deployment configuration having adumbbell shape. The device 200 p includes a first, upper wire mesh 261at its proximal end and a second, lower wire mesh 262 at its distal end.The internal volumes of the two wire meshes 261, 262 are in fluidcommunication with one another. In various embodiments, the size of thesecond wire mesh 262 is equal to or smaller than the size of the upperwire mesh 261. The device 200 p further includes a first opening 263 atthe proximal end of the upper wire mesh 261 and a second, larger opening264 at the distal end of the lower wire mesh 262. Food enters the device200 p at the first opening 263, travels through the internal volume ofthe upper wire mesh 261, into and through the internal volume of thelower wire mesh 262, and exits through the second opening 264. In oneembodiment, the wire mesh of the lower wire mesh portion 262 is anextension of the wire mesh of the upper wire mesh portion 261. Inanother embodiment, the two wire mesh portions 261, 262 are comprised ofseparate wire mesh structures which are then attached prior todeployment. In the pictured embodiment, the device 200 p includes amembrane 267 covering the entire outer surface of the device 200 p withthe exception of the two openings 263, 264.

In various embodiments, the device 200 p has a total length rangingbetween 50 and 500 mm. In a preferred embodiment, the device 200 p has atotal length of 180 mm. In various embodiments, the upper wire mesh 261has a length ranging between 70 and 250 mm. In a preferred embodiment,the upper wire mesh 261 has a length of 140 mm. In various embodiments,the lower wire mesh 262 has a length ranging between 30 and 250 mm. In apreferred embodiment, the lower wire mesh 262 has a length of 40 mm. Invarious embodiments, the upper wire mesh 261 has a width ranging between70 and 170 mm. In a preferred embodiment, the upper wire mesh 261 has awidth of 120 mm. In various embodiments, the lower wire mesh 262 has awidth ranging between 20 and 170 mm. In a preferred embodiment, thelower wire mesh 262 has a width of 60 mm. In various embodiments, thefirst opening 263 has a diameter ranging between 5 and 30 mm. In apreferred embodiment, the first opening 263 has a diameter of 20 mm. Invarious embodiments, the second opening 264 has a diameter ranging from10 to 45 mm. In a preferred embodiment, the second opening 264 has adiameter of 30 mm.

FIG. 2Q is an illustration of a first exemplary wire mesh structure 291shape in a post-deployment configuration, in accordance with oneembodiment of the present specification. In the pictured embodiment, thewire mesh structure 291 has a spherical shape.

FIG. 2R is an illustration of a second exemplary wire mesh structure 292shape in a post-deployment configuration, in accordance with oneembodiment of the present specification. In the pictured embodiment, thewire mesh structure 292 has a kidney bean shape.

FIG. 2S is an illustration of a third exemplary wire mesh structure 292shape in a post-deployment configuration, in accordance with oneembodiment of the present specification. In the pictured embodiment, thewire mesh structure 293 has an oval shape.

FIG. 2T is an illustration of a fourth exemplary wire mesh structure 294shape in a post-deployment configuration, in accordance with oneembodiment of the present specification. In the pictured embodiment, thewire mesh structure 294 has a shape that approximates that of a stomachand of a boot, with the lower, toe shaped portion positioned proximateto the pylorus.

FIG. 2U is an illustration of a fifth exemplary wire mesh structure 295shape in a post-deployment configuration, in accordance with oneembodiment of the present specification. In the pictured embodiment, thewire mesh structure 295 has an ovoid or inverted egg shape.

FIG. 3A is an illustration of a wire mesh structure 301 and coupledsleeve 360 of an intragastric device 300 a in a post-deploymentconfiguration in accordance with one embodiment of the presentspecification, depicting the wire mesh structure 301 with the weavepattern as shown in FIG. 2B. The wire mesh structure 301 has a length lwhich is greater than its width w. The wire mesh structure 301 comprisesan upper portion 321, a lower portion 322, a proximal wire mesh header323, and a first opening 320 at its proximal end. The wire meshstructure 301 also includes a second opening at its distal end which iscovered entirely by the coupled sleeve 360 and therefore not visible inFIG. 3A. In the pictured embodiment, the first opening 320 at theproximal end of the wire mesh structure 301 is smaller than the secondopening at its distal end leading into the sleeve 360. In oneembodiment, the sleeve 360 is coupled to the wire mesh structure 301 viasutures.

The sleeve 360 includes a sleeve body 361 having a proximal end, adistal end and a lumen within. The sleeve body 361 is comprised of aflexible and compressible mesh material. The sleeve body 361 includes afirst opening (not shown) at its proximal end and a second opening 375at its distal end. The first opening 320 of the wire mesh structure 301is in fluid communication with the internal volume of the wire meshstructure 301, which is in fluid communication with the second openingof the wire mesh structure. The second opening of the wire meshstructure 301 is in fluid communication with the first opening of thesleeve body 361, which is in fluid communication with the lumen of thesleeve body 361. Finally, the lumen of the sleeve body 361 is in fluidcommunication with the second opening 375 at the distal end of thesleeve body 361.

Once deployed, the device 300 a is positioned within thegastrointestinal tract of a patient such that the wire mesh structure301 is positioned in the mid/distal stomach with the lower portion 322resting just proximal to the antrum or the pylorus. The sleeve 360passes through the pylorus and extends into the duodenum. Food entersthe first opening 320 of the wire mesh structure 301, passes through theinternal volume of the wire mesh structure 301, through the secondopening of the wire mesh structure and the first opening of the sleevebody 361, through the lumen of the sleeve body 361, and exits thethrough the second opening 375 of the sleeve body 361. Food that travelsthrough the device 300 a effectively bypasses the pylorus and proximalportion of the small intestine.

FIG. 3B is an illustration of a wire mesh structure 303 and coupledsleeve 362 of an intragastric device 300 b in a post-deploymentconfiguration in accordance with another embodiment of the presentspecification, depicting the wire mesh structure 302 with the weavepattern as shown in FIG. 2C. The wire mesh structure 302 has a length lwhich is greater than its width w. The wire mesh structure 302 comprisesan upper portion 331, a lower portion 332, a proximal wire mesh header333, a distal wire mesh footer 334, and a first opening 330 at itsproximal end. The wire mesh structure 302 also includes a second openingat its distal end which is covered entirely by the coupled sleeve 362and therefore not visible in FIG. 3B. In the pictured embodiment, thefirst opening 330 at the proximal end of the wire mesh structure 302 islarger than the second opening at its distal end leading into the sleeve362. In one embodiment, the sleeve 362 is coupled to the wire meshstructure 302 via sutures.

The sleeve 362 includes a sleeve body 363 having a proximal end, adistal end and a lumen within. The sleeve body 363 is comprised of aflexible and compressible mesh material. The sleeve body 363 includes afirst opening (not shown) at its proximal end and a second opening 376at its distal end. Food travels through the device 300 b in a similarmanner as discussed with reference to FIG. 3A.

FIG. 3C is an illustration of a wire mesh structure 303 and coupledsleeve 364 of an intragastric device 300 c in a post-deploymentconfiguration in accordance with another embodiment of the presentspecification, depicting the wire mesh structure 303 with the weavepattern as shown in FIG. 2D. The wire mesh structure 303 has a length lwhich is less than its width w. The wire mesh structure 303 comprises anupper portion 341, a lower portion 342, a proximal wire mesh header 343,and a first opening 340 at its proximal end. The wire mesh structure 303also includes a second opening at its distal end which is coveredentirely by the coupled sleeve 364 and therefore not visible in FIG. 3C.In the pictured embodiment, the first opening 340 at the proximal end ofthe wire mesh structure 303 is smaller than the second opening at itsdistal end leading into the sleeve 364. In one embodiment, the sleeve364 is coupled to the wire mesh structure 303 via sutures or glued orbonded to the mesh structure.

The sleeve 364 includes a sleeve body 365 having a proximal end, adistal end and a lumen within. The sleeve body 365 is comprised of aflexible and compressible mesh material. The sleeve body 365 includes afirst opening (not shown) at its proximal end and a second opening 377at its distal end. Food travels through the device 300 c in a similarmanner as discussed with reference to FIG. 3A.

FIG. 3D is an illustration of a wire mesh structure 304 and coupledsleeve 366 of an intragastric device 300 d in a post-deploymentconfiguration in accordance with yet another embodiment of the presentspecification, depicting the wire mesh structure 304 with the weavepattern as shown in FIG. 2E. The wire mesh structure 304 has a length lwhich is less than its width w. The wire mesh structure 304 comprises anupper portion 351, a lower portion 352, a proximal wire mesh header 353,and a first opening 350 at its proximal end. The wire mesh structure 304also includes a second opening at its distal end which is coveredentirely by the coupled sleeve 366 and therefore not visible in FIG. 3D.In the pictured embodiment, the first opening 350 at the proximal end ofthe wire mesh structure 304 is smaller than the second opening at itsdistal end leading into the sleeve 366. In one embodiment, the sleeve366 is coupled to the wire mesh structure 304 via sutures.

The sleeve 366 includes a sleeve body 367 having a proximal end, adistal end and a lumen within. The sleeve body 367 is comprised of aflexible and compressible mesh material. The sleeve body 367 includes afirst opening (not shown) at its proximal end and a second opening 378at its distal end. Food travels through the device 300 d in a similarmanner as discussed with reference to FIG. 3A.

FIG. 4A is an illustration of a wire mesh structure 401 with retrievalmechanism 481 and coupled sleeve 460 of an intragastric device 400 a ina post-deployment configuration in accordance with one embodiment of thepresent specification, depicting the wire mesh structure 401 with theweave pattern as shown in FIG. 2B. The wire mesh structure 401 has alength l which is greater than its width w. The wire mesh structure 401comprises an upper portion 421, a lower portion 422, a proximal wiremesh header 423, and a first opening 420 at its proximal end. Aretrieval mechanism 481 extends proximally from the proximal wire meshheader 423. In one embodiment, the retrieval mechanism 481 includes aretrieval loop 482. In one embodiment, the retrieval mechanism 481 is anextension of the wire comprising the proximal wire mesh header 423. Inanother embodiment, the retrieval mechanism 481 is a separate piece ofwire that is fixedly attached to the proximal wire mesh header 423. Thewire mesh structure 401 also includes a second opening at its distal endwhich is covered entirely by the coupled sleeve 460 and therefore notvisible in FIG. 4A. In the pictured embodiment, the first opening 420 atthe proximal end of the wire mesh structure 401 is smaller than thesecond opening at its distal end leading into the sleeve 460. In oneembodiment, the sleeve 460 is coupled to the wire mesh structure 401 viasutures.

The sleeve 460 includes a sleeve body 461 having a proximal end, adistal end and a lumen within. The sleeve body 461 is comprised of aflexible and compressible mesh material. The sleeve body 461 includes afirst opening (not shown) at its proximal end and a second opening 475at its distal end. The first opening 420 of the wire mesh structure 401is in fluid communication with the internal volume of the wire meshstructure 401, which is in fluid communication with the second openingof the wire mesh structure. The second opening of the wire meshstructure 401 is in fluid communication with the first opening of thesleeve body 461, which is in fluid communication with the lumen of thesleeve body 461. Finally, the lumen of the sleeve body 461 is in fluidcommunication with the second opening 475 at the distal end of thesleeve body 461.

Once deployed, the device 400 a is positioned within thegastrointestinal tract of a patient such that the wire mesh structure401 is positioned in the distal stomach with the lower portion 422resting just proximal to the antrum or the pylorus. The sleeve 460passes through the pylorus and extends into the duodenum. Food entersthe first opening 420 of the wire mesh structure 401, passes through theinternal volume of the wire mesh structure 401, through the secondopening of the wire mesh structure and the first opening of the sleevebody 461, through the lumen of the sleeve body 461, and exits thethrough the second opening 475 of the sleeve body 461. Food that travelsthrough the device 400 a effectively bypasses the pylorus and proximalportion of the small intestine.

FIG. 4B is an illustration of a wire mesh structure 402 with retrievalhook 483 and coupled sleeve 462 of an intragastric device 400 b in apost-deployment configuration in accordance with another embodiment ofthe present specification, depicting the wire mesh structure 402 withthe weave pattern as shown in FIG. 2C. The wire mesh structure 402 has alength l which is greater than its width w. The wire mesh structure 402comprises an upper portion 431, a lower portion 432, a proximal wiremesh header 433, a distal wire mesh footer 434, and a first opening 430at its proximal end. A retrieval mechanism 483 extends proximally fromthe proximal wire mesh header 433. In one embodiment, the retrievalmechanism 483 includes a retrieval loop 484. In one embodiment, theretrieval mechanism 483 is an extension of the wire comprising theproximal wire mesh header 433. In another embodiment, the retrievalmechanism 483 is a separate piece of wire that is fixedly attached tothe proximal wire mesh header 433. The wire mesh structure 402 alsoincludes a second opening at its distal end which is covered entirely bythe coupled sleeve 462 and therefore not visible in FIG. 4B. In thepictured embodiment, the first opening 430 at the proximal end of thewire mesh structure 402 is larger than the second opening at its distalend leading into the sleeve 462. In one embodiment, the sleeve 462 iscoupled to the wire mesh structure 402 via sutures.

The sleeve 462 includes a sleeve body 463 having a proximal end, adistal end and a lumen within. The sleeve body 463 is comprised of aflexible and compressible mesh material. The sleeve body 463 includes afirst opening (not shown) at its proximal end and a second opening 476at its distal end. Food travels through the device 400 b in a similarmanner as discussed with reference to FIG. 4A.

FIG. 4C is an illustration of a wire mesh structure 403 with retrievalmechanism 485 and coupled sleeve 464 of an intragastric device 400 c ina post-deployment configuration in accordance with another embodiment ofthe present specification, depicting the wire mesh structure 403 withthe weave pattern as shown in FIG. 2D. The wire mesh structure 403 has alength l which is less than its width w. The wire mesh structure 403comprises an upper portion 441, a lower portion 442, a proximal wiremesh header 443, and a first opening 440 at its proximal end. Aretrieval mechanism 485 extends proximally from the proximal wire meshheader 443. In one embodiment, the retrieval mechanism 485 includes aretrieval loop 486. In one embodiment, the retrieval hook 485 is anextension of the wire comprising the proximal wire mesh header 443. Inanother embodiment, the retrieval mechanism 485 is a separate piece ofwire that is fixedly attached to the proximal wire mesh header 443. Thewire mesh structure 403 also includes a second opening at its distal endwhich is covered entirely by the coupled sleeve 464 and therefore notvisible in FIG. 4C. In the pictured embodiment, the first opening 440 atthe proximal end of the wire mesh structure 403 is smaller than thesecond opening at its distal end leading into the sleeve 464. In oneembodiment, the sleeve 464 is coupled to the wire mesh structure 403 viasutures.

The sleeve 464 includes a sleeve body 465 having a proximal end, adistal end and a lumen within. The sleeve body 465 is comprised of aflexible and compressible mesh or a wire material. The sleeve body 465includes a first opening (not shown) at its proximal end and a secondopening 477 at its distal end. Food travels through the device 400 c ina similar manner as discussed with reference to FIG. 4A.

FIG. 4D is an illustration of a wire mesh structure 404 with retrievalmechanism 487 and coupled sleeve 466 of an intragastric device 400 d ina post-deployment configuration in accordance with yet anotherembodiment of the present specification, depicting the wire meshstructure 404 with the weave pattern as shown in FIG. 2E. The wire meshstructure 404 has a length l which is less than its width w. The wiremesh structure 404 comprises an upper portion 451, a lower portion 452,a proximal wire mesh header 453, and a first opening 450 at its proximalend. A retrieval mechanism 487 extends proximally from the proximal wiremesh header 453. In one embodiment, the retrieval mechanism 487 includesa retrieval loop 488. In one embodiment, the retrieval mechanism 487 isan extension of the wire comprising the proximal wire mesh header 453.In another embodiment, the retrieval mechanism 487 is a separate pieceof wire that is fixedly attached to the proximal wire mesh header 453.The wire mesh structure 404 also includes a second opening at its distalend which is covered entirely by the coupled sleeve 466 and thereforenot visible in FIG. 4D. In the pictured embodiment, the first opening450 at the proximal end of the wire mesh structure 404 is smaller thanthe second opening at its distal end leading into the sleeve 466. In oneembodiment, the sleeve 466 is coupled to the wire mesh structure 404 viasutures.

The sleeve 466 includes a sleeve body 467 having a proximal end, adistal end and a lumen within. The sleeve body 467 is comprised of aflexible and compressible mesh material. The sleeve body 467 includes afirst opening (not shown) at its proximal end and a second opening 478at its distal end. Food travels through the device 400 d in a similarmanner as discussed with reference to FIG. 4A.

FIG. 5A is an illustration of a wire mesh structure 501 with retrievalhook 581, coupled sleeve 560, and anti-migration component 591 of anintragastric device 500 a in a post-deployment configuration inaccordance with one embodiment of the present specification, depictingthe wire mesh structure 501 with the weave pattern as shown in FIG. 2B.The wire mesh structure 501 has a length l which is greater than itswidth w. The wire mesh structure 501 comprises an upper portion 521, alower portion 522, a proximal wire mesh header 523, and a first opening520 at its proximal end. A retrieval mechanism 581 extends proximallyfrom the proximal wire mesh header 523. In one embodiment, the retrievalmechanism 581 includes a retrieval loop 582. In one embodiment, theretrieval mechanism 581 is an extension of the wire comprising theproximal wire mesh header 523. In another embodiment, the retrievalmechanism 581 is a separate piece of wire that is fixedly attached tothe proximal wire mesh header 523. The wire mesh structure 501 alsoincludes a second opening at its distal end which is covered entirely bythe coupled sleeve 560 and therefore not visible in FIG. 5A. In thepictured embodiment, the first opening 520 at the proximal end of thewire mesh structure 501 is smaller than the second opening at its distalend leading into the sleeve 560. In one embodiment, the sleeve 560 iscoupled to the wire mesh structure 501 via sutures.

The sleeve 560 includes a sleeve body 561 having a proximal end, adistal end and a lumen within. The sleeve body 561 is comprised of aflexible and compressible mesh material. The sleeve body 561 includes afirst opening (not shown) at its proximal end and a second opening 575at its distal end. The first opening 520 of the wire mesh structure 501is in fluid communication with the internal volume of the wire meshstructure 501, which is in fluid communication with the second openingof the wire mesh structure. The second opening of the wire meshstructure 501 is in fluid communication with the first opening of thesleeve body 561, which is in fluid communication with the lumen of thesleeve body 561. Finally, the lumen of the sleeve body 561 is in fluidcommunication with the second opening 575 at the distal end of thesleeve body 561.

An anti-migration component 591 is positioned at the junction of thewire mesh structure 501 with the sleeve 560. In the pictured embodiment,the anti-migration component 591 has the shape of a distally slopingdisc and is comprised of a wire mesh with a silicone covering. In oneembodiment, the anti-migration component 591 is fixedly attached to thelower portion 522 of the wire mesh structure 501 via sutures.

Once deployed, the device 500 a is positioned within thegastrointestinal tract of a patient such that the wire mesh structure501 is positioned in the distal stomach with the lower portion 522resting proximal to the pylorus. The anti-migration component 591 sitsjust proximal to the pylorus and acts as a physical stopper, preventingdistal migration of the entirety of the device 500 a through the pylorusand into the duodenum. The sleeve 560 passes through the pylorus andextends into the duodenum. Food enters the first opening 520 of the wiremesh structure 501, passes through the internal volume of the wire meshstructure 501, through the second opening of the wire mesh structure andthe first opening of the sleeve body 561, through the lumen of thesleeve body 561, and exits the through the second opening 575 of thesleeve body 561. Food that travels through the device 500 a effectivelybypasses the pylorus and proximal portion of the small intestine.

FIG. 5B is an illustration of a wire mesh structure 502 with retrievalhook 583, coupled sleeve 562, and anti-migration component 592 of anintragastric device 500 b in a post-deployment configuration inaccordance with another embodiment of the present specification,depicting the wire mesh structure 502 with the weave pattern as shown inFIG. 2C. The wire mesh structure 502 has a length l which is greaterthan its width w. The wire mesh structure 502 comprises an upper portion531, a lower portion 532, a proximal wire mesh header 533, a distal wiremesh footer 534, and a first opening 530 at its proximal end. Aretrieval mechanism 583 extends proximally from the proximal wire meshheader 533. In one embodiment, the retrieval mechanism 583 includes aretrieval loop 584. In one embodiment, the retrieval mechanism 583 is anextension of the wire comprising the proximal wire mesh header 533. Inanother embodiment, the retrieval mechanism 583 is a separate piece ofwire that is fixedly attached to the proximal wire mesh header 533. Thewire mesh structure 502 also includes a second opening at its distal endwhich is covered entirely by the coupled sleeve 562 and therefore notvisible in FIG. 5B. In the pictured embodiment, the first opening 530 atthe proximal end of the wire mesh structure 502 is larger than thesecond opening at its distal end leading into the sleeve 562. In oneembodiment, the sleeve 562 is coupled to the wire mesh structure 502 viasutures.

The sleeve 562 includes a sleeve body 563 having a proximal end, adistal end and a lumen within. The sleeve body 563 is comprised of aflexible and compressible mesh material. The sleeve body 563 includes afirst opening (not shown) at its proximal end and a second opening 576at its distal end. An anti-migration component 592 is positioned at thejunction of the wire mesh structure 502 with the sleeve 562. In thepictured embodiment, the anti-migration component 592 has the shape of adistally sloping disc and is comprised of a wire mesh with a siliconecovering. In one embodiment, the anti-migration component 592 is fixedlyattached to the lower portion 532 of the wire mesh structure 502 viasutures. The anti-migration component 592 prevents distal migration ofthe entirety of the device 500 b through the pylorus and into theduodenum. Food travels through the device 500 b in a similar manner asdiscussed with reference to FIG. 5A.

FIG. 5C is an illustration of a wire mesh structure 503 with retrievalhook 585, coupled sleeve 564, and anti-migration component 593 of anintragastric device 500 c in a post-deployment configuration inaccordance with another embodiment of the present specification,depicting the wire mesh structure 503 with the weave pattern as shown inFIG. 2D. The wire mesh structure 503 has a length l which is less thanits width w. The wire mesh structure 503 comprises an upper portion 541,a lower portion 542, a proximal wire mesh header 543, and a firstopening 540 at its proximal end. A retrieval hook 585 extends proximallyfrom the proximal wire mesh header 543. In one embodiment, the retrievalhook 585 includes a retrieval loop 586. In one embodiment, the retrievalhook 585 is an extension of the wire comprising the proximal wire meshheader 543. In another embodiment, the retrieval hook 585 is a separatepiece of wire that is fixedly attached to the proximal wire mesh header543. The wire mesh structure 503 also includes a second opening at itsdistal end which is covered entirely by the coupled sleeve 564 andtherefore not visible in FIG. 5C. In the pictured embodiment, the firstopening 540 at the proximal end of the wire mesh structure 503 issmaller than the second opening at its distal end leading into thesleeve 564. In one embodiment, the sleeve 564 is coupled to the wiremesh structure 503 via sutures.

The sleeve 564 includes a sleeve body 365 having a proximal end, adistal end and a lumen within. The sleeve body 565 is comprised of aflexible and compressible mesh material. The sleeve body 565 includes afirst opening (not shown) at its proximal end and a second opening 577at its distal end. An anti-migration component 593 is positioned at thejunction of the wire mesh structure 503 with the sleeve 564. In thepictured embodiment, the anti-migration component 593 has the shape of adistally sloping disc and is comprised of a wire mesh with a siliconecovering. In one embodiment, the anti-migration component 593 is fixedlyattached to the lower portion 542 of the wire mesh structure 503 viasutures. The anti-migration component 593 prevents distal migration ofthe entirety of the device 500 c through the pylorus and into theduodenum. Food travels through the device 500 c in a similar manner asdiscussed with reference to FIG. 5A.

FIG. 5D is an illustration of a wire mesh structure 504 with retrievalhook 587, coupled sleeve 566, and anti-migration component 594 of anintragastric device 500 d in a post-deployment configuration inaccordance with yet another embodiment of the present specification,depicting the wire mesh structure 504 with the weave pattern as shown inFIG. 2E. The wire mesh structure 504 has a length l which is less thanits width w. The wire mesh structure 504 comprises an upper portion 551,a lower portion 552, a proximal wire mesh header 553, and a firstopening 550 at its proximal end. A retrieval hook 587 extends proximallyfrom the proximal wire mesh header 553. In one embodiment, the retrievalhook 587 includes a retrieval loop 588. In one embodiment, the retrievalhook 587 is an extension of the wire comprising the proximal wire meshheader 553. In another embodiment, the retrieval hook 587 is a separatepiece of wire that is fixedly attached to the proximal wire mesh header553. The wire mesh structure 504 also includes a second opening at itsdistal end which is covered entirely by the coupled sleeve 566 andtherefore not visible in FIG. 5D. In the pictured embodiment, the firstopening 550 at the proximal end of the wire mesh structure 504 issmaller than the second opening at its distal end leading into thesleeve 566. In one embodiment, the sleeve 566 is coupled to the wiremesh structure 504 via sutures.

The sleeve 566 includes a sleeve body 567 having a proximal end, adistal end and a lumen within. The sleeve body 567 is comprised of aflexible and compressible mesh material. The sleeve body 567 includes afirst opening (not shown) at its proximal end and a second opening 578at its distal end. An anti-migration component 594 is positioned at thejunction of the wire mesh structure 504 with the sleeve 566. In thepictured embodiment, the anti-migration component 594 has the shape of adistally sloping disc and is comprised of a wire mesh with a siliconecovering. In one embodiment, the anti-migration component 594 is fixedlyattached to the lower portion 552 of the wire mesh structure 504 viasutures. The anti-migration component 594 prevents distal migration ofthe entirety of the device 500 d through the pylorus and into theduodenum. Food travels through the device 500 d in a similar manner asdiscussed with reference to FIG. 5A.

FIGS. 6A through 6S depict various exemplary configurations of wire meshweave patterns, 600 a, 600 b, 600 c, 600 d, 600 e, 600 f, 600 g, 600 h,600 i, 600 j, 600 k, 6001, 600 m, 600 n, 600 o, 600 p, 600 q, 600 r, and600 s comprised within the intragastric device. As shown in the Figures,the mesh weave can have a plurality of different configurations, withvarying degrees of density between the wires components and varyingsizes of holes defining the mesh structure. The spatial density may bedefined in a plurality of dimensions, including along lengths and spacesa, b, c, d, e, f, g, h, i, j, and k as seen in FIGS. 6A through 6C. Anyof the depicted weave patterns can be used for the wire mesh structureof an intragastric device of the present specification. Those skilled inthe art would recognize that the wire mesh structure can have any numberof different weave patterns that enable it to be compressed for deliveryand retrieval and provide it with adequate radial strength once deployedsuch that it will not be passed through the pylorus as a result ofgastric contractions.

FIG. 7 is a flow chart illustrating the steps involved during themanufacture of an intragastric device having a corrosion-resistantcoating, in accordance with one embodiment of the present specification.At step 702, a flexible metal wire, such as a shape memory metal wire,is manipulated, formed, and heat-set into a desired post-deploymentshape for an intragastric device in accordance with the devicesdisclosed in the present specification. Then, at step 704, the device isdipped in its entirety into a corrosion-resistant material, silicone,comprising silicone and methylbenzene in a weight ratio range of1:100-25:100. The material has been heated that it is in a liquid state.The device is then removed from the liquid material at step 706. Some ofthe material sticks to the wires and is allowed to air dry for aspecific amount of time, becoming a solid coating over the wires of thedevice. Steps 704 and 706 are repeated as the device is dipped into thematerial multiple times, followed by air drying after each dip, untilthe coating reaches a desired thickness. At step 708, coating iscompleted once the thickness of the corrosion-resistant material is in arange of 0.001-0.010 inches.

FIG. 7B is a flow chart illustrating the steps involved during themanufacture of an intragastric device having a corrosion-resistantcoating, in accordance with another embodiment of the presentspecification. At step 712, a flexible metal wire, such as a shapememory metal wire, is manipulated, formed, and heat-set into a desiredpost-deployment shape for an intragastric device in accordance with thedevices disclosed in the present specification. Then, at step 714, thedevice is sprayed with a vapor deposition of a corrosion-resistantmaterial. In one embodiment, the corrosion-resistant material isparylene. The device is allowed to air dry for a specific amount of timesuch that the vapor deposition hardens into a solid form at step 716.Steps 714 and 716 are repeated multiple times until the desired coatingthickness is achieved. Coating is completed at step 718 once thecorrosion-material thickness is in a range of 0.001-0.010 inches.

FIG. 7C is a flow chart illustrating the steps involved during themanufacture of an intragastric device having a corrosion-resistantcoating, in accordance with yet another embodiment of the presentspecification. The method comprises applying a first coating of a firstcorrosion-resistant material and then applying a second coating of asecond corrosion-resistant material to provide additional protection. Atstep 722, a flexible metal wire, such as a shape memory metal wire, ismanipulated, formed, and heat-set into a desired post-deployment shapefor an intragastric device in accordance with the devices disclosed inthe present specification. Then, at step 724, the device is dipped inits entirety into a first corrosion-resistant material, silicone,comprising silicone and methylbenzene in a weight ratio range of1:100-25:100. The material has been heated that it is in a liquid state.The device is then removed from the liquid material at step 726. Some ofthe material sticks to the wires and is allowed to air dry for aspecific amount of time, becoming a solid coating over the wires of thedevice. Steps 724 and 726 are repeated as the device is dipped into thematerial multiple times, followed by air drying after each dip, untilthe coating reaches a desired thickness. At step 728, the first coatingis completed once the thickness of the first corrosion-resistantmaterial is in a range of 0.001-0.005 inches. At step 730, the device isthen sprayed with a vapor deposition of a second corrosion-resistantmaterial. In one embodiment, the second corrosion-resistant material isparylene. The device is allowed to air dry for a specific amount of timesuch that the vapor deposition hardens into a solid form at step 732.Steps 730 and 732 are repeated multiple times until the desired coatingthickness is achieved. The second coating is completed at step 734 oncethe second corrosion-material thickness is in a range of 0.001-0.005inches.

FIGS. 8 and 9 are oblique side view illustrations of the proximal end ofan intragastric device 800, 900 in a post-deployment configuration inaccordance with one embodiment of the present specification, depictingfirst 810, 910 and second 815, 915 openings in the proximal and distalends, respectively of a wire mesh structure 801, 901 of the device 800,900. Devices 800, 900 each further include a retrieval hook 803, 903,coupled sleeve 802, 902, and anti-migration disc 804, 904. As can beseen in FIGS. 8 and 9 , the first openings 810, 910 of both devices 800,900 are smaller than the second openings 815, 915 of the devices 800,900. Referring to FIG. 8 , a first sleeve opening 820 is depicted at theproximal end of the sleeve 802 in fluid communication with the secondopening 815 of the wire mesh structure 801. The sleeve 802 also includesa second opening (not shown) at or proximate its distal end.

FIG. 10 is an illustration of one embodiment of an intragastric device1000 of the present specification in a post-deployment configuration,depicting a sleeve component 1002 as it would conform to the shape ofthe proximal small intestine. In the pictured embodiment, the sleeve1002 is comprised of a flexible mesh material that allows it to bend asit traverses the small intestine. The mesh material also allows thesleeve 1002 to be compressed by the contractions of the small intestineand re-expand as it fills with food that enters the sleeve 1002 from thecoupled wire mesh structure 1001. The sleeve 1002 includes an elongatetube having a proximal end, a distal end, and a lumen within. Theproximal end of the sleeve 1002 is attached to the distal end of thewire mesh structure 1001 such that an opening in the distal end of thewire mesh structure 1001 is in fluid communication with the lumen of thesleeve 1002. Food is sequestered within the wire mesh structure 1001,enters the sleeve 1002 via the opening in the distal end of the wiremesh structure 1001, and passes through the sleeve 1002 and into theproximal jejunum, thus bypassing the stomach and duodenum.

FIG. 11 is a side view illustration of one embodiment of an intragastricdevice 1100 of the present specification in a post-deploymentconfiguration, depicting a wire mesh structure 1101, retrieval hook1103, coupled sleeve 1102, and distally sloping anti-migration disc1104. The wire mesh structure 1101 is substantially oval shaped andfunctions to occupy volume in a patient's stomach. The anti-migrationdisc 1104 prevents slippage of the wire mesh portion 1101 of the device1100 through the pylorus. Making the disc 1104 have a distally slopingshape allows it to function as an upside-down funnel, helping to keepthe wire mesh structure 1101 out of the pylorus. The sleeve 1102transmits food from the wire mesh structure 1101 past the pylorus andduodenum.

FIG. 12 is an oblique side view illustration of one embodiment of anintragastric device 1200 of the present specification in apost-deployment configuration, depicting a second opening 1215 at thedistal end of a wire mesh structure 1201 and the underside of a distallysloping anti-migration disc 1204. The wire mesh structure also includesa first opening 1210 at its proximal end. The second opening 1215 at thedistal end of the wire mesh structure 1201 is in fluid communicationwith a first opening 1220 of a coupled sleeve 1202. In the picturedembodiment, the disc 1204 includes a collar 1205 that fits about thejunction of the wire mesh structure 1201 with the sleeve 1202.

FIG. 13A is an illustration of a wire mesh structure 1301 in apost-deployment configuration with a distally sloping anti-migrationdisc 1304 attached to its distal end, in accordance with one embodimentof the present specification. A first opening 1310 at the proximal endof the wire mesh structure 1301 and a second opening 1315 at the distalend of the wire mesh structure 1301 are also visible. FIG. 13B is anillustration of a wire mesh structure 1351 in a post-deploymentconfiguration with a proximally sloping anti-migration disc 1354attached to its distal end, in accordance with one embodiment of thepresent specification. A first opening 1360 at the proximal end of thewire mesh structure 1351 and a second opening 1365 at the distal end ofthe wire mesh structure 1351 are also visible. In one embodiment, theproximally sloping anti-migration disc 1354 helps direct food that haspassed the first opening 1360 through the openings 1355 between thewires 1357 and into the wire mesh structure 1351. In variousembodiments, the attachment of the disc to the mesh could allow for thesame disc to assume different sloping configurations.

FIG. 14 is an illustration depicting the expansion of an intragastricdevice having a half sphere wire mesh structure 1401, anti-migrationcomponent 1404, and sleeve 1402 during deployment, in accordance withone embodiment of the present specification. For implantation, thedevice is compressible into an elongate, narrow compressed configuration1400 a. The narrow shape of the device in this configuration allows fordelivery of the device through the working channel of an endoscope orthrough the esophagus over a guidewire or an endoscope or through anovertube. Once the device is passed beyond the distal end of theendoscope channel, it begins to passively expand 1400 b, getting larger1400 c until it reaches its fully deployed configuration 1400 d.

FIG. 15A is an illustration of a first exemplary anti-migrationcomponent 1501 shape in a post-deployment configuration, in accordancewith one embodiment of the present specification. In the picturedembodiment, the anti-migration component 1501 has a half-bumper shape.

FIG. 15B is an illustration of a second exemplary anti-migrationcomponent 1502 shape in a post-deployment configuration, in accordancewith one embodiment of the present specification. In the picturedembodiment, the anti-migration component 1502 has a proximally extendingflower shape.

FIG. 15C is an illustration of a third exemplary anti-migrationcomponent 1503 shape in a post-deployment configuration, in accordancewith one embodiment of the present specification. In the picturedembodiment, the anti-migration component 1503 has a full-bumper shape.

FIG. 15D is an illustration of a fourth exemplary anti-migrationcomponent 1504 shape in a post-deployment configuration, in accordancewith one embodiment of the present specification. In the picturedembodiment, the anti-migration component 1504 has a saucer shape.

FIG. 15E is an illustration of a fifth exemplary anti-migrationcomponent 1505 shape in a post-deployment configuration, in accordancewith one embodiment of the present specification. In the picturedembodiment, the anti-migration component 1505 has a funnel shape.

FIG. 15F is an illustration of a sixth exemplary anti-migrationcomponent 1506 shape in a post-deployment configuration, in accordancewith one embodiment of the present specification. In the picturedembodiment, the anti-migration component 1506 has a funnel shape.

FIG. 15G is an illustration of a seventh exemplary anti-migrationcomponent 1507 shape in a post-deployment configuration, in accordancewith one embodiment of the present specification. In the picturedembodiment, the anti-migration component 1507 has a flower shape.

FIG. 15H is an illustration of an eighth exemplary anti-migrationcomponent 1508 shape in a post-deployment configuration, in accordancewith one embodiment of the present specification. In the picturedembodiment, the anti-migration component 1508 has a circular shape.

FIG. 16 is an illustration of a wire mesh structure 1601 in apost-deployment configuration with a flower-shaped, proximally slopinganti-migration disc 1604 attached to its distal end, in accordance withone embodiment of the present specification. The wire mesh structure1601 has an oval shape and includes a retrieval mechanism 1603. In oneembodiment, the retrieval mechanism is a silk suture loop. The disc 1604helps prevent the wire mesh structure 1601 from entering and passingthrough the pylorus or gastrojejunostomy following an RGB procedure. Inone embodiment, the wire mesh structure 1601 includes a bulbous,predominantly spherical or ovoid proximal end and an expanded distalend. In one embodiment, the distal half of the structure is covered witha membrane to impede the passage of food out of the structure 1601,directing the food through a distal opening. In one embodiment, thestructure 1601 has an optional anti-reflux valve at the proximal end andanother optional valve at the distal end. The valve at the distal endacts to control the flow of chyme or partially digested food from theinside of the structure 1601 to the outside of the structure 1601. Invarious other embodiments, the structure 1601 includes differentlyshaped wire meshes including, but not limited to, those discussed withreference to FIGS. 6A through 6S.

FIG. 17A is an illustration of a sleeve component 1702 of anintragastric device in accordance with one embodiment of the presentspecification, depicting horizontal 1722 and vertical support elements1724, a proximal first opening 1721, and a side second opening 1726proximate the distal end of the sleeve 1702. The horizontal supportelements 1722 serve to maintain the sleeve 1702 in an elongate shape inthe duodenum and to keep the sleeve lumen open. The vertical supportelements 1724 help keep the lumen of the sleeve 1702 open aftercontractions have compressed the sleeve 1702, thereby allowing moreingested food to enter the sleeve 1702 from a coupled wire meshstructure (not shown). The vertical support elements 1724 also keep thesegments of the sleeve 1702 straight and prevent segments from foldingor buckling. The horizontal 1722 and vertical 1724 support elements alsoimpart anti-torsional properties to the sleeve 1702 so that it will notbecome twisted as a result of exposure to intestinal contractions. Inaddition, in one embodiment, the horizontal support elements 1722 andvertical support elements 1724 additionally act as weighted structureskeeping the sleeve 1702 in place in the gastrointestinal tract. Thesleeve 1702 further includes a blind pouch 1727 at its distal end,distal to the second opening 1726. Food and fluid intermittently collectand are trapped in this pouch 1727, thereby weighting down the distalend of the sleeve 1702 and helping to maintain the sleeve 1702 in anelongated shape. This weighted distal end is designed to pull the tubedistally into the small bowel maintaining it in a predominantlystraightened position. In various embodiments, the length of the blindpouch 1727 is in a range from one half inch to 12 inches beyond thedistal opening 1726. In another embodiment, the distal end is weighteddown by incorporating a weighted structure into the length of the sleevecomponent 1702. Food traveling down the sleeve 1702 after entering froma wire mesh device into the proximal first opening 1721 exits the sleeve1702 at the second opening 1726. In addition, food that has been caughtin the pouch 1727 is intermittently pushed out of the pouch 1727 and outthe second opening 1702 by intestinal contractions. In one embodiment,the sleeve component 1702 includes one or more valves 1725 to preventretrograde flow of food within the sleeve component 1703.

In various embodiments, the horizontal support elements 1722 are spacedbetween 1 inches and 24 inches apart from one another and the verticalsupport elements 1724 are between 1 inches and 60 inches in length. Inone embodiment, the horizontal support elements are spaced 6 inchesapart from one another and the vertical support elements are 6 inches inlength. It is desirable that the sleeve be flexible, while also beingtorsion, buckling or kink resistant, and could be made of any materialthat allows it to have these properties.

In various embodiments, the sleeve component is made ofpolytetrafluoroethylene (PTFE) or polyethylene or cast PTFE (e.g.,Teflon), PTFE with fluorinated ethylene propylene (FEP) orperfluoroalkoxy (PFA) coating, extruded FEP and extruded PFA or extrudedPTFE or a fluoropolymer or silicone. In various embodiments, the sleevecomponent has a length in a range of 6 inches to 6 feet or longer. Inone embodiment, the sleeve component has a length of 24 inches. Inanother embodiment, the sleeve component has a length of 30 inches. Invarious embodiments, the sleeve component has a diameter in a range of 1cm to 10 cm. In one embodiment, the sleeve component has a diameter of 3cm.

FIG. 17B is an illustration of a sleeve component 1703 of anintragastric device in accordance with one embodiment of the presentspecification, depicting horizontal 1732 and vertical support elements1734, a proximal first opening 1731, and a second opening 1736 at thedistal end of the sleeve 1703. The horizontal support elements 1732serve to maintain the sleeve 1703 in an elongate shape in the duodenum.The vertical support elements 1734 help keep the lumen of the sleeve1703 open after contractions have compressed the sleeve 1703, therebyallowing more ingested food to enter the sleeve 1703 from a coupled wiremesh structure (not shown). The horizontal 1732 and vertical 1734support elements also impart anti-torsional properties to the sleeve1703 so that it will not become twisted as a result of exposure tointestinal contractions. Food traveling down the sleeve 1703 afterentering from the proximal first opening 1731 exits the sleeve 1703 atthe second opening 1736. In one embodiment, the sleeve component 1703includes one or more valves 1735 to prevent retrograde flow of foodwithin the sleeve component 1703.

FIG. 17C is an illustration of a sleeve component 1704 of anintragastric device in accordance with one embodiment of the presentspecification, depicting a coil or wire mesh support 1743, a proximalfirst opening 1741, and a side second opening 1746 proximate the distalend of the sleeve 1704. The wire mesh support 1743 serves to maintainthe sleeve 1704 in an elongate shape in the duodenum and keep the lumenof the sleeve 1704 open after contractions have compressed the sleeve1704, thereby allowing more ingested food to enter the sleeve 1704 froma coupled wire mesh structure (not shown). The wire mesh support 1743also imparts anti-torsional properties to the sleeve 1704 so that itwill not become twisted as a result of exposure to intestinalcontractions. The sleeve 1704 further includes a blind pouch 1747 at itsdistal end, distal to the second opening 1746. Food intermittentlycollects in this pouch 1747, thereby weighting down the distal end ofthe sleeve 1704 and helping to maintain the sleeve 1704 in an elongatedshape. Food traveling down the sleeve 1704 after entering from theproximal first opening 1741 exits the sleeve at the second opening 1746.In addition, food that has been caught in the pouch 1747 isintermittently pushed out of the pouch 1747 and out the second opening1704 by intestinal contractions.

FIG. 17D is an illustration of a sleeve component 1705 of anintragastric device in accordance with one embodiment of the presentspecification, depicting a wire mesh support 1753, a proximal firstopening 1751, and a second opening 1756 at the distal end of the sleeve1705. The wire mesh support 1753 serves to maintain the sleeve 1705 inan elongate shape in the duodenum and keep the lumen of the sleeve 1705open after contractions have compressed the sleeve 1705, therebyallowing more ingested food to enter the sleeve 1705 from a coupled wiremesh structure (not shown). The wire mesh support 1753 also impartsanti-torsional properties to the sleeve 1705 so that it will not becometwisted as a result of exposure to intestinal contractions. Foodtraveling down the sleeve 1705 after entering from the proximal firstopening 1751 exits the sleeve at the second opening 1756.

FIG. 17E is an illustration of a sleeve component 1706 of anintragastric device in accordance with one embodiment of the presentspecification, depicting a spiral wire support 1768, a proximal firstopening 1761, and a side second opening 1766 proximate the distal end ofthe sleeve 1706. The spiral wire support 1768 serves to maintain thesleeve 1706 in an elongate shape in the duodenum and keep the lumen ofthe sleeve 1706 open after contractions have compressed the sleeve 1706,thereby allowing more ingested food to enter the sleeve 1706 from acoupled wire mesh structure (not shown). The spiral wire support 1768also imparts anti-torsional properties to the sleeve 1706 so that itwill not become twisted as a result of exposure to intestinalcontractions. The sleeve 1706 further includes a blind pouch 1767 at itsdistal end, distal to the second opening 1766. Food intermittentlycollects in this pouch 1767, thereby weighting down the distal end ofthe sleeve 1706 and helping to maintain the sleeve 1706 in an elongatedshape. Food traveling down the sleeve 1706 after entering from theproximal first opening 1761 exits the sleeve at the second opening 1766.In addition, food that has been caught in the pouch 1767 isintermittently pushed out of the pouch 1767 and out the second opening1706 by intestinal contractions.

FIG. 17F is an illustration of a sleeve component 1707 of anintragastric device in accordance with one embodiment of the presentspecification, depicting a spiral wire support 1778, a proximal firstopening 1771, and a second opening 1776 at the distal end of the sleeve1707. The spiral wire support 1778 serves to maintain the sleeve 1707 inan elongate shape in the duodenum and keep the lumen of the sleeve 1707open after contractions have compressed the sleeve 1707, therebyallowing more ingested food to enter the sleeve 1707 from a coupled wiremesh structure (not shown). The spiral wire support 1778 also impartsanti-torsional properties to the sleeve 1707 so that it will not becometwisted as a result of exposure to intestinal contractions. Foodtraveling down the sleeve 1707 after entering from the proximal firstopening 1771 exits the sleeve at the second opening 1776. One or morespiral wires can be used based on desired rigidity, kink, torsion orbuckle resistance. Wires of different material or wire diameter can beused.

FIG. 18A is an illustration of another embodiment of an intragastricdevice 1800 with a coupled sleeve 1802 in an exemplary post-deploymentconfiguration and FIG. 18B is a cross-sectional illustration of theembodiment of an intragastric device 1800 with a coupled sleeve 1802 inan exemplary post-deployment configuration of FIG. 18A. The device 1800includes a wire mesh structure 1801 having a first opening 1803 at itsproximal end and a second, larger opening 1804 at its distal end. Thedevice 1800 is covered by a membrane 1805 about its entire outer surfacewith the exception of at the first 1803 and second 1804 openings. Thedevice 1800 further includes an anti-migration component 1806 in theshape of a bumper at its distal end. The anti-migration component 1806is formed from an extension of the wire mesh of the device 1800 and isalso covered by the membrane 1805. A sleeve 1802 is coupled to thedistal end of the wire mesh structure 1801 of the device 1800 andincludes a first sleeve opening 1807 and a second sleeve opening 1808.The proximal end of the sleeve 1802 entirely covers the second, largeropening 1804 of the wire mesh structure 1801 such that the first sleeveopening 1807 is in fluid communication with the second, larger opening1804 of the wire mesh structure 1801 and food is allowed to pass fromthe wire mesh structure 1801 into the sleeve 1802. In one embodiment,the sleeve 1802 is deployed in the gastrointestinal tract of the patientsuch that the second sleeve opening 1808 is positioned within thejejunum of the patient, allowing food to bypass the pylorus and duodenumand empty into said jejunum.

FIG. 18C is an illustration of an embodiment of an intragastric device1810 having a dumbbell shape with a coupled sleeve 1812 in an exemplarypost-deployment configuration. The device 1810 includes an upper wiremesh portion 1811 and a lower wire mesh portion 1819. A first opening1813 is positioned at the proximal end of the upper wire mesh portion1811 and a second, larger opening 1814 is positioned at the distal endof the lower wire mesh portion 1819. In the pictured embodiment, amembrane 1815 covers the entire outer surfaces of both wire meshportions 1811, 1819 with the exception of the two openings 1813, 1814. Asleeve 1812 is coupled to a portion of the lower wire mesh portion 1819.The sleeve 1812 includes a first sleeve opening 1817 covering, and influid communication with, the second opening 1814 at the distal end ofthe lower wire mesh portion 1819. The sleeve 1812 further includes asecond sleeve opening 1818 at its distal end. Food enters the device1810 through the first opening 1813 at the proximal end of the upperwire mesh 1811 and then travels through the upper wire mesh 1811 andlower wire mesh 1819. The food then passes through the second opening1814 at the distal end of the lower wire mesh 1819, through first sleeveopening 1817, and into the sleeve 1812. Finally, food exits the device1810 through the second sleeve opening 1818. In one embodiment, thedevice 1810 is deployed with the distal end of the sleeve 1812positioned in the jejunum so the food exiting the device 1810 throughthe second sleeve opening 1818 empties into said jejunum. In variousembodiments, the proximal end of the sleeve is coupled to any portion ofthe lower wire mesh 1819 or to a distal portion of the upper wire mesh1811.

FIG. 18D is an illustration depicting various exemplary post-deploymentconfiguration intragastric devices 1820, 1830, 1840, 1850, 1860, 1870 inaccordance with multiple embodiments of the present specification.Intragastric device 1820 comprises a wire mesh structure 1821 with asleeve 1822 coupled to its distal end. The sleeve 1822 includescircumferential support elements to maintain sleeve shape and the wiremesh structure 1821 includes a narrow bumper shaped anti-migrationcomponent 1823. Intragastric device 1830 comprises a wire mesh structure1831 with a coupled sleeve 1832. The wire mesh structure 1830 includes abumper shaped anti-migration component 1833 that is wider than theanti-migration component 1823 depicted on device 1820. Intragastricdevice 1840 and intragastric device 1850 each include a wire meshstructure 1841, 1851 and a coupled sleeve 1842, 1852. The sleeve 1842 ofdevice 1840 is coupled to the wire mesh structure 1841 such that theproximal portion of the sleeve 1842 is positioned within the distalportion of the wire mesh structure 1841. Conversely, with respect todevice 1850, the sleeve 1852 is coupled to the wire mesh structure 1851such that the proximal portion of the sleeve 1852 covers the outersurface of the distal portion of the wire mesh structure 1851.Intragastric device 1860 comprises a wire mesh structure 1861 with athin coupled sleeve 1862. The device 1860 includes a distally extending,disc shaped anti-migration component 1863 positioned at the junction ofthe wire mesh structure 1861 and the sleeve 1862. Intragastric device1870 also comprises a wire mesh structure 1871 with a coupled sleeve1872 and includes a distally extending, disc shaped anti-migrationcomponent 1873 positioned at the junction of the wire mesh structure1871 and the sleeve 1872. Device 1870 further includes a retrieval hook1874 attached to the proximal end of the wire mesh structure 1871 tofacilitate removal of the device 1870 from a human body. Intragastricdevice 1875 also comprises a wire mesh structure 1876 with a coupledsleeve 1877 and includes a bumper shaped anti-migration component 1878similar to that seen in device 1830. However, the sleeve 1877 of device1875 extends over anti-migration component 1878 and is coupled to theouter edge of the anti-migration component 1878 such that food enteringthrough the holes in the anti-migration component 1878 enters into thesleeve 1877.

FIG. 18E is an illustration of another embodiment of an intragastricdevice 1880 with a wire mesh structure 1881 and an attached sleeve 1882in an exemplary pre-deployment configuration. The pre-deploymentconfiguration takes a compressed, cylindrical shape to facilitateinsertion.

FIG. 18F is an illustration of the intragastric device 1890 with a wiremesh structure 1891 and an attached sleeve 1892 of FIG. 18E in anexemplary post-deployment configuration. The post-deploymentconfiguration takes an expanded, honeycomb shape to occupy gastricvolume and permit the sequestering of food within the device 1890. Inone embodiment, the honeycomb shaped device is covered with a membrane(not shown) containing openings of the same or different sizes. In oneembodiment, the openings have valves composed of the same membranousmaterial to direct the flow of food preferentially into the device. Inone embodiment, the device 1890 contains one large opening 1894 at thebottom that is wholly covered by the attached sleeve 1892. The opening1894 at the bottom of the device 1890 allows for the preferentialpassage of food into the sleeve 1892 which in turn delivers the foodinto the jejunum.

FIG. 19A is an illustration of one embodiment of an intragastric device1900 in a post-deployment configuration having first sleeve 1902 andsecond sleeves 1930 coupled to a wire mesh structure 1901. The wire meshstructure includes an upper portion 1911 and a lower portion 1912. Thefirst sleeve 1902 is coupled directly to the distal end of the lowerportion 1912 such that the sleeve 1902 covers a second opening 1915 atthe distal end of the wire mesh structure 1901. In one embodiment, thefirst sleeve 1902 is coupled to the lower portion 1912 of the wire meshstructure via sutures. The second sleeve 1930 is coupled to the any partof the lower portion 1912 of the wire mesh structure 1901, at a distanceaway from the wire mesh structure 1901, in a manner that the distal endof the first sleeve 1902 passes through a proximal first opening 1931 inthe second sleeve 1930 and comes to rest within said second sleeve 1930.The second sleeve 1930 is coupled to the lower portion 1912 of the wiremesh structure 1901 via one or more connecting elements 1913. In oneembodiment, the connecting elements 1913 comprise sutures or thread orwire.

Once deployed, the device 1900 is positioned such that the wire meshstructure 1900 sits in the stomach just proximal to the pylorus, thefirst sleeve 1902 extends from the wire mesh structure 1901 through thepylorus and into the duodenum, and the second sleeve 1930 sits in theduodenum and/or jejunum. A distal portion of the first sleeve 1902 ispositioned within a proximal portion of the second sleeve 1930 and theconnecting elements 1913 extend from the wire mesh structure 1901,through the pylorus and a portion of the duodenum and/or jejunum, and tothe proximal end of the second sleeve 1930.

Food entering the stomach and intestines can follow one of two paths.Following a first path, food can enter the wire mesh structure 1901 viathe first opening 1910 at its proximal end, pass through the wire meshstructure 1901, through the second opening 1915 at the distal end of thewire mesh structure 1901, and into the first sleeve 1902 through a firstopening 1920 at its proximal end. The food then passes through the firstsleeve 1902, exits the first sleeve 1902 through a second opening 1925at its distal end, and enters the second sleeve 1930. Finally, foodtravels through the second sleeve 1930, exits the second sleeve 1930through a second opening 1936 at its distal end, and passes into theduodenum or jejunum.

Following a second pathway, food that does not enter but bypasses thewire mesh structure 1901 flows past the first sleeve 1902 and enters thesecond sleeve 1930 via the first opening 1931 at its proximal end. Foodthen travels through the second sleeve 1930, exits the second sleeve1930 through a second opening 1936 at its distal end, and passes intothe duodenum or jejunum. The pictured embodiment is useful for capturingfood that flows around the wire mesh structure 1901 as it bobs up anddown in the stomach, allowing for that food to still bypass portions ofthe duodenum and/or jejunum. In the pictured embodiment, the secondsleeve 1930 includes an optional blind pouch 1937 distal to the secondopening 1936 that captures food intermittently, weighting down thesecond sleeve 1930 and keeping it in an elongated shape. Intestinalcontractions intermittently compress the pouch 1937, pushing the foodback out of the pouch 1937 and through the second opening 1936. Invarious embodiments, the first and second sleeves are comprised ofdifferent support elements and have varying second openings with orwithout pouches as described with reference to FIGS. 17A through 17F.

In another embodiment, the first opening 1920 of the first sleeve 1902completely covers, encases, or otherwise envelopes any and all of secondopening or openings 1915 at the distal end of the wire mesh structure1901 so that all chyme released from the wire mesh structure 1901 willenter only into the first sleeve 1902. The second sleeve 1930 isattached to the wire mesh structure 1901 using connecting elements 1913,such as, wires, sutures or strings, and the first opening 1931 of thesecond sleeve 1930 resides in the proximal duodenum to capture any foodthat does not enter the wire mesh structure 1901 but passes alongsidethe wire mesh structure 1901 through the pylorus into the duodenum.

FIG. 19B is an illustration of one embodiment of an intragastric device1950 in a post-deployment configuration having one sleeve 1980 coupledto a wire mesh structure 1951 at a distance distally away from said wiremesh structure 1951. The wire mesh structure 1951 includes an upperportion 1961 and a lower portion 1962. The sleeve 1980 is coupled to thewire mesh structure 1951 using connecting elements 1963, such as, wires,sutures or strings that are attached to the lower portion 1962 of thewire mesh structure 1951.

Once deployed, the device 1950 is positioned such that the wire meshstructure 1951 sits in the stomach proximal to the antrum or the pylorusand the sleeve 1980 sits in the duodenum and/or jejunum with the opening1981 preferably in the patient's duodenum. Food entering the stomach andintestines can follow multiple paths. Food can enter the wire meshstructure 1951 via the first opening 1960 at its proximal end, passthrough the wire mesh structure 1951, and exit through the secondopening 1965 at the distal end of the wire mesh structure 1951 back intothe stomach. In this situation the wire mesh structure acts to reducefood intake and slow the passage of food from the stomach into theduodenum by delaying gastric emptying. Food can then pass through thepylorus and into the small intestine and then pass through the sleeve1980, as described below.

Food that either passes through the wire mesh structure 1951 or thatdoes not enter but bypasses the wire mesh structure 1951 can enter thesleeve 1980 via the first opening 1981 at its proximal end. Food thentravels through the sleeve 1980, exits the sleeve 1980 through a secondopening 1986 at its distal end, and passes into the duodenum or jejunum.The pictured embodiment is useful for capturing food that flows aroundthe wire mesh structure 1951 as it bobs up and down in the stomach,allowing for that food to still bypass portions of the duodenum and/orjejunum. In the pictured embodiment, the sleeve 1980 includes a blindpouch 1987 distal to the second opening 1986 that captures foodintermittently, weighting down the sleeve 1980 and keeping it in anelongated shape. Intestinal contractions intermittently compress thepouch 1987, pushing the food back out of the pouch 1987 and through thesecond opening 1986. In various embodiments, the second sleeve iscomprised of different support elements and has varying second openingswith or without pouches as described with reference to FIGS. 17A through17F.

FIG. 19C is an illustration of another embodiment of an intragastricdevice 1970 in a post-deployment configuration having one sleeve 1990coupled to a wire mesh structure 1975 at a distance distally away fromsaid wire mesh structure 1975. The wire mesh structure 1975 includes anupper portion 1976 with a first opening 1971 and a lower portion 1977with a second opening 1972. The sleeve 1990 includes a first opening1991 and a second opening 1996 with a blind pouch 1997 at its distalend. The device 1970 functions similarly to the device 1950 describedwith reference to FIG. 19B, the only difference being the location ofattachment of the connecting elements 1973 to the wire mesh structure1975. Referring to FIG. 19C, the connecting elements 1973 attach to thewire mesh structure 1975 at the location of the second opening 1972.

FIG. 20 is an illustration of one embodiment of an intragastric device2000 in a post-deployment configuration having a wire mesh structure2001 and a sleeve 2002 coupled to the wire mesh structure 2001 and amembrane 2005 covering both the sleeve 2002 and wire mesh structure2001. The device 2000 is depicted in the post-deployment configuration.In one embodiment, the membrane 2005 is flexible and non-porous. In oneembodiment, the membrane 2005 covers the entire outer surface of thewire mesh structure 2001 with the exception of the first opening 2010 atits proximal end. The membrane 2005 covers the entire outer surface ofthe sleeve 2002 with the exception of the second opening 2025 at itsdistal end. The membrane 2005 prevents any food from entering or exitingthe wire mesh structure 2001 in the spaces 2008 between the wires 2007of the wire mesh structure 2001. Food passing through the device 2000can only do so by entering at the first opening 2010 of the wire meshstructure 2001, traveling through the wire mesh structure 2001 and thesleeve 2002, and then exiting the sleeve 2002 at its second opening2025. Alternatively, the food could enter the wire mesh through theother openings in the wire mesh.

Occasionally, food that enters the wire mesh structure can encounterdifficulty in exiting the structure due to stasis or bezoar formation.This will interfere in proper functioning of the device. Therefore, invarious embodiments, it is desirable to include mechanisms to assistwith emptying of the wire mesh structure.

FIG. 2I is an illustration of one embodiment of an intragastric device2100 in a post-deployment configuration having a half sphere wire meshstructure 2101 and a sleeve 2102 coupled to the wire mesh structure2101. Since the device 2100 has no ‘upper portion’ as described withreference to spherical wire mesh structures above, the opening 2110 atthe top of the ‘lower portion’ 2112 acts as the proximal first opening2110. The ‘lower portion’ 2112 further includes a second opening (notshown) at its distal end. The sleeve 2102 includes a first opening (notshown) at its proximal end in fluid communication with the secondopening of the ‘lower portion’ 2112 of the wire mesh structure 2101.Food enters the wire mesh structure 2101 through the first opening 2110of the ‘lower portion’ 2112, passes through the ‘lower portion’ 2112,through the second opening at the distal end of the lower portion,through the first opening at the proximal end of the sleeve, into andthrough the sleeve 2102 and then out of the device 2100 at the secondopening at the distal end of the sleeve 2102. Food that does not exitthrough the second opening due to particle size will exit the wire meshlower structure 2101 via the large proximal first opening 2110 when thepatient is in the supine position. This food will then exit the stomachnormally through the pylorus. Allowing for emptying of the devicewhenever the patient is in the supine position prevents stasis andbezoar formation.

FIG. 22 is an illustration of one embodiment of an intragastric device2200 in a post-deployment configuration having a wire mesh structure2201 and a sleeve 2202 coupled to the wire mesh structure 2201 and amembrane 2205 covering the sleeve 2202 and wire mesh structure 2201,depicting a plurality of openings 2255 in the membrane 2205. Themembrane 2205 covers the entire outer surface of both the wire meshstructure and the sleeve with the exception of the first opening at theproximal end of the wire mesh structure 2210, the second opening at thedistal end of the sleeve 2225, and the plurality of openings 2255 in themembrane 2205. In one embodiment, the plurality of openings 2255 in themembrane 2205 aligns with the spaces 2208 between the wires 2207 in thewire mesh structure 2201. Besides the proximal to distal pathway of foodthrough the device as discussed with reference to multiple embodimentsabove, food can pass into the wire mesh structure 2201 through theopenings 2255 in the membrane 2205. In one embodiment, the membrane 2205further includes unidirectional valves or flaps 2256 that allow food topass into the wire mesh structure 2201 at the plurality of openings 2255and prevent food from flowing back out through the same openings 2255.

FIG. 23A is an illustration of one embodiment of an intragastric device2300 a in a post-deployment configuration having a wire mesh structure2301 and a sleeve 2302 coupled to the wire mesh structure 2301. The wiremesh structure 2301 includes an upper portion 2311 and a lower portion2312. Referring to FIG. 23A, the upper portion 2311 and the lowerportion 2312 of the wire mesh structure 2301 have the same weave patternand radial strength to resist compression by gastric contractions.

FIG. 23B is an illustration of one embodiment of an intragastric device2300 b in a post-deployment configuration having a wire mesh structure2321 and a sleeve 2322 coupled to the wire mesh structure 2321, whereinthe upper portion 2331 of the wire mesh structure 2321 comprises a wiremesh and the lower portion 2332 comprises only a membrane. The upperportion 2331 of the wire mesh structure 2321 comprises a weave patternthat provides the upper portion 2331 with a radial strength great enoughto prevent it from being substantially compressed by gastriccontractions. In one embodiment, the upper portion 2331 includes aplurality of openings for passage of food into the device. Themembranous composition of the lower portion 2332 allows the force ofgastric contractions to pass through the lower portion 2332 and reachthe food inside, helping to push the food down through the wire meshstructure 2321 and into the sleeve 2322. Antral contractions are fullytransmitted to the partially digested food in the lower portion 2332,agitating the food and squeezing it through the opening at the distalend of the lower portion 2332 and into the sleeve 2322.

FIG. 23C is an illustration of one embodiment of an intragastric device2300 c in a post-deployment configuration having a wire mesh structure2341 and a sleeve 2342 coupled to the wire mesh structure 2341, whereinthe upper portion 2351 of the wire mesh structure 2341 has a greaterradial strength than the lower portion 2352. The upper portion 2351 hasa greater radial force that is provided by its denser weave pattern whencompared with the weave pattern of the lower portion 2352. The upperportion 2351 of the wire mesh structure 2341 comprises a weave patternthat provides the upper portion 2351 with a radial strength great enoughto prevent it from being substantially compressed by gastriccontractions, thereby resisting significant distortion and maintainingits shape. In one embodiment, the upper portion 2351 includes aplurality of openings to allow food to enter the device. The less denseweave pattern of the lower portion 2352 allows the force of gastriccontractions to pass through the lower portion 2352 and reach the foodinside, helping to push the food down through the wire mesh structure2341 and into the sleeve 2342. The wire mesh lower portion 2352 hasenough radial force to maintain its shape in the absence of gastriccontractions, but it does not resist distortion caused by thecontractions when they occur. The gastric contractions are transmittedto the lumen of the wire mesh lower portion 2352 to cause agitation andactive propulsion of the food within the lower portion 2352 through anopening at its distal end and into the sleeve 2342. Antral contractionssqueeze the food out of the lower portion 2352 and into the sleeve 2342.In various embodiments, the differential radial strength can beconstructed by using different size wires or by using different meshweave patterns.

FIG. 24A is an illustration of a first exemplary double-wire meshintragastric device 2400 a in a post-deployment configuration inaccordance with one embodiment of the present specification. Thepictured embodiment includes a first wire mesh structure 2401 positionedon top of a second wire mesh structure 2411 and a sleeve 2402 coupled tothe distal end of the second wire mesh structure 2411. A firstanti-migration component 2404 at the base of the first wire meshstructure 2401 rests inside the second wire mesh structure 2411 andfunctions to couple the two wire mesh structures 2401, 2411 together.The first anti-migration component 2404 also helps to prevent the secondwire mesh structure 2411 from being compressed by gastric contractionsand keeps the device 2400 a out of the pylorus. A second anti-migrationcomponent 2414, at the base of the second wire mesh structure 2411, actsto prevent the entirety of the device 2400 a from being passed throughthe pylorus. Food first passes through openings in the top of thecombined intragastric device 2400 a and is sequestered in the first wiremesh structure 2401. The food then slowly passes into, and issequestered in, the second wire mesh structure 2411. Finally, the foodslowly releases through the openings in the bottom of the combinedintragastric device 2400 a and back into the stomach. The combined wiremesh structures 2401, 2411 work together to occupy an increased volumein a patient's stomach and further delay the passage of food through thegastrointestinal tract. The combined two wire mesh structures 2401, 2411also act to induce satiety even more quickly and induce a longer lastingsatiety than a single mesh structure device.

FIG. 24B is an illustration of a second exemplary double-wire meshintragastric device 2400 b in a post-deployment configuration inaccordance with one embodiment of the present specification. Thepictured embodiment includes a first wire mesh structure 2421 positionedon top of a second wire mesh structure 2431. The two wire meshstructures 2421, 2431 work together to occupy an increased volume in apatient's stomach and further delay the passage of food through thegastrointestinal tract.

FIG. 24C is an illustration of a third exemplary double-wire meshintragastric device 2400 c in a post-deployment configuration inaccordance with one embodiment of the present specification. Thepictured embodiment includes a first wire mesh structure 2451 positionedon top of a second wire mesh structure 2461. An anti-migration component2464 at the base of the second wire mesh structure 2461 acts to preventthe entirety of the device 2400 c from being passed through the pylorus.The two wire mesh structures 2451, 2461 work together to occupy anincreased volume in a patient's stomach and further delay the passage offood through the gastrointestinal tract.

FIG. 24D is an illustration of a fourth exemplary double-wire meshintragastric device 2400 d in a post-deployment configuration inaccordance with one embodiment of the present specification. Thepictured embodiment includes a first wire mesh structure 2471 positionedon top of a second wire mesh structure 2481. A first anti-migrationcomponent 2474 at the base of the first wire mesh structure 2471 restsinside the second wire mesh structure 2481 and functions to couple thetwo wire mesh structures 2471, 2481 together. The first anti-migrationcomponent 2474 also helps to prevent the second wire mesh structure 2481from being compressed by gastric contractions and keeps the device 2400d out of the pylorus. A second anti-migration component 2484 at the baseof the second wire mesh structure 2481 acts to prevent the entirety ofthe device 2400 d from being passed through the pylorus. The two wiremesh structures 2471, 2481 work together to occupy an increased volumein a patient's stomach and further delay the passage of food through thegastrointestinal tract.

FIG. 24E is an illustration of a fifth exemplary double-wire meshintragastric device 2400 e in a post-deployment configuration inaccordance with one embodiment of the present specification. Thepictured embodiment includes a first wire mesh structure 2491 positionedon top of a second wire mesh structure 2499 and a sleeve 2492 coupled tothe distal end of the second wire mesh structure 2499. An anti-migrationcomponent 2494 at the base of the second wire mesh structure 2499 actsto prevent the entirety of the device 2400 e from being passed throughthe pylorus. The two wire mesh structures 2491, 2499 work together tooccupy an increased volume in a patient's stomach and further delay thepassage of food through the gastrointestinal tract.

FIG. 25 is an illustration of one embodiment of an intragastric device2500 in a post-deployment configuration having a wire mesh structure2501, anti-migration disc 2504, and sleeve 2502, depicting a membrane2505 covering the sleeve 2502 and a lower portion of the wire meshstructure 2501. In the pictured embodiment, the membrane 2505 covers theentire outer surface of the sleeve 2502 with the exception of a secondopening 2525 along its length and proximate its distal end. The membrane2505 covering the sleeve 2502 extends onto a portion of the wire meshstructure 2501. In various embodiments, the membrane 2505 covers 0 to100% of the outer surface of the wire mesh structure 2501, with theexception of a first opening 2510 at the proximal end of the wire meshstructure 2501.

In one embodiment, the wire mesh structure 2501 includes a first valve2530 at the first opening 2510 to prevent reflux of food into theesophagus. In one embodiment, the wire mesh structure 2501 furtherincludes a second valve 2533 at the junction between the wire meshstructure 2501 and the sleeve 2502 to direct food into the sleeve 2502and prevent the flow of food back into the wire mesh structure 2501. Inone embodiment, the sleeve 2502 includes one or more valves 2527 toprevent retrograde flow of food proximally within the sleeve 2502.

FIG. 26A is an illustration of a portion of a patient's gastrointestinaltract following a sleeve gastrectomy procedure. A large portion of thestomach 2605 along the greater curvature has been removed, effectivelycreating a “sleeve” 2610 along the lesser curvature. The sleeve 2610connects the esophagus 2615 with the duodenum 2620. The procedureeliminates the reservoir function of the stomach, thereby limitingcaloric intake and resulting in weight loss and control of diabetes.

FIG. 26B is an illustration of a portion of a patient's gastrointestinaltract following a roux-en-y gastric bypass (RGB) procedure. Most of thestomach 2607 and a proximal portion of the duodenum 2620 are resectedand bypassed. A small gastric pouch 2608 is created and connected to thejejunum 2625, allowing food to pass from the esophagus 2615 via thepouch 2608 into the jejunum 2625. Pancreatico-biliary juices pass fromthe duodenum 2620 into the jejunum 2625 at an anastomosis point 2623. Aswith sleeve gastrectomy, the RGB procedure eliminates the reservoirfunction of the stomach, thereby limiting caloric intake and resultingin weight loss and control of diabetes.

FIG. 27 is an illustration of one embodiment of an intragastric device2705 with an attached device sleeve 2710 deployed in a stomach 2715 andduodenum 2720 following a sleeve gastrectomy procedure. In oneembodiment, the device 2705 comprises a spherical or ovoid shaped wiremesh structure 2707 having a proximal end and a distal end and amembrane covering a portion of the wire mesh. A device sleeve 2710 isattached to the distal end of the wire mesh structure 2707 and passesthrough the pylorus 2717 and duodenum 2720 and into the jejunum 2725. Inone embodiment, the wire mesh structure 2707 includes a plurality ofsmall openings to allow for the passage of partially digested food intothe device 2705, through the device sleeve 2710, and into the jejunum2725. In one embodiment, the device 2705 includes one or more anchoringelements 2706 that anchor the device 2705 into the created gastricsleeve, preventing migration of the device 2705. In one of theembodiment, an anti-migration structure is attached at the junction ofthe mesh and sleeve and prevents the device from migrating out of thestomach.

The device acts to further restrict the capacity of the gastric sleevefollowing the sleeve gastrectomy procedure. The device sequesters thepartially digested food and passes it through the device sleeve, therebybypassing the duodenum. This routing of food effectively creates aduodenal bypass and biliopancreatic dissociation, increasing the weightloss benefits provided by the sleeve gastrectomy procedure.

FIG. 28A is an illustration of another embodiment of an intragastricdevice 2805 with a proximal tubular end 2802 and an attached devicesleeve 2810 deployed in a stomach 2801 and duodenum 2820 following asleeve gastrectomy procedure. In one embodiment, the device 2805comprises an elongate, club shaped tube 2802 having a proximal end and aspherical distal end 2803. In one embodiment, the distal end has adiameter greater than that of the proximal end and rests in the distalantrum 2821. The tube 2802 is designed to conform to the shape of thecreated gastric sleeve 2801 and is placed with its proximal end justdistal to the esophagus 2815. The tube 2802 includes a first opening atits proximal end to receive food from the esophagus 2815 and a secondopening at its distal end to release food into the duodenum 2820 or intoan attached device sleeve 2810. In one embodiment, the proximal endincludes a valve 2830 to allow food to enter the tube 2802 and toprevent the reflux of gastric contents into the esophagus 2815. In oneembodiment, an optional device sleeve 2810 is attached to the distal endof the tube 2802 and passes through the pylorus 2817 and duodenum 2820and into the jejunum 2825. The device 2805 acts to further restrict thecapacity of the gastric sleeve 2801 following the sleeve gastrectomyprocedure. The device 2805 sequesters the partially digested food andpasses it through the device tube 2802 and optional sleeve 2810, therebycompletely bypassing the stomach 2801 and duodenum 2820. FIG. 28Adepicts a cross-section of the device 2805 showing the tubular proximalportion 2802 which curves outward to form the spherical distal end 2803,with the sleeve 2010 attached to the spherical distal end 2803.

FIG. 28B is an illustration of an embodiment of an intragastric device2805 with a proximal tubular end 2802 and an attached device sleeve 2810similar to the device of the embodiment of FIG. 28A, depicting thedevice 2805 deployed in a stomach 2801 and duodenum 2820 following asleeve gastrectomy procedure. In one embodiment, the device 2805comprises an elongate, club shaped tube 2802 having a proximal end and adistal end. In one embodiment, the distal end has a diameter greaterthan that of the proximal end. The tube 2802 is designed to conform tothe shape of the created gastric sleeve and is placed with its proximalend just distal to the esophagus 2815. The tube 2802 includes a firstopening at its proximal end to receive food from the esophagus 2815 anda second opening at its distal end to release food into the duodenum2820 or into an attached device sleeve 2810. In one embodiment, theproximal end includes a valve 2830 to allow food to enter the tube 2802and to prevent the reflux of gastric contents into the esophagus 2815.In one embodiment, the device 2805 includes one or more anchors 2840along the length of the tube 2802 to anchor the device 2805 in thecreated gastric sleeve and prevent migration. In one embodiment, anoptional device sleeve 2810 is attached to the distal end of the tube2802 and passes through the pylorus 2817 and duodenum 2820 and into thejejunum 2825. The device 2805 acts to further restrict the capacity ofthe gastric sleeve 2801 following the sleeve gastrectomy procedure. Thedevice 2805 sequesters the partially digested food and passes it throughthe device tube 2802 and optional sleeve 2810, thereby completelybypassing the stomach 2801 and duodenum 2820.

FIG. 29 is an illustration of another embodiment of an intragastricdevice 2905 with an attached device sleeve 2910 deployed in the gastricpouch 2950 following a roux-en-y gastric bypass (RGB) procedure. In oneembodiment, the device 2905 comprises a spherical wire mesh structure2907 having a proximal end and a distal end. The proximal end of thewire mesh structure 2907 has one or more openings to allow food to enterfrom the esophagus 2915. In one embodiment, the wire mesh structure 2907has one opening at its proximal end for food to enter and includes ananti-reflux valve 2930 at the opening to prevent food from refluxinginto the esophagus 2915. The distal end of the structure 2907 is coveredby a membrane that prevents food from exiting through the wire mesh. Anopening is positioned at the bottom of the distal end of the wire meshstructure 2907. In one embodiment, a device sleeve 2910 is attached tothe distal end of the wire mesh structure 2907. The device sleeve 2910extends through the jejunum 2925 to a point beyond the anastomosis 2923of the jejunum 2925 with the duodenum 2920. Food passes from theesophagus 2915 into the wire mesh structure 2907 and through the devicesleeve 2910, bypassing the stomach 2909, duodenum 2920, and proximalportion of the jejunum 2925. The device assists with weight loss byfurther slowing the emptying of food from the gastric pouch 2950.

In one embodiment, the device 2905 further includes one or moreanchoring mechanisms 2940 to anchor the device 2905 in the gastric pouch2950 and prevent migration. In one embodiment, the anchoring mechanisms2940 are attached to the wire mesh structure 2907. In one embodiment,the anchoring mechanisms 2940 are barbs. In one embodiment, the device2905 further includes one or more weighting mechanisms 2942 attached tothe device sleeve 2910 to position the device sleeve 2910 in the smallbowel. In various embodiments, the weighting mechanisms 2942 include anyone or combination of metal beads, metal rings and fluid filled pockets.Other mechanisms known in the art can be used to add weight to thedevice sleeve 2910.

FIG. 30 is an illustration of another embodiment of an intragastricdevice 3005 in a post-deployment configuration with an attached devicesleeve 3010 for implantation into the gastric pouch of a patientfollowing a roux-en-y gastric bypass (RGB) procedure. In the embodimentdepicted in FIG. 30 , the device sleeve 3010 is attached to the proximalopening 3004 of the wire mesh structure 3007 and extends distallythrough the structure 3007 and into the jejunum. In one embodiment, thedevice sleeve 3010 extends at least 12 inches beyond the distal end ofthe wire mesh structure 3007. The wire mesh structure 3007 allows foranchoring of the device 3005 in the gastric pouch. Food passes from theesophagus into the proximal opening 3004 of the device 3005, through thedevice sleeve 3010, and into the small intestine. In one embodiment, thedevice sleeve 3010 includes one or more valves 3012 to preventretrograde flow of food or small intestine contents. In variousembodiments, a portion or whole of the wire mesh is covered by amembrane. FIG. 30 depicts a cross-section of an embodiment of the device3005 where the spherical mesh 3007 is formed by the everted proximal endof the device 3005, creating the proximal opening 3004. The sleeve 3010is attached to a distal opening 3015 of the mesh.

FIG. 31 is an illustration of an expanded wire mesh structure 3101 of afirst intragastric device 3100 in a post-deployment configuration and aconstricted wire mesh structure 3121 of a second intragastric device3120 coupled to the distal end of an implantation catheter 3150, inaccordance with one embodiment of the present specification. Secondintragastric device 3120 also includes a sleeve 3122 coupled to thedistal end of the wire mesh structure 3121. The wire mesh structure 3121and sleeve 3122 of the second intragastric device 3120 have beencompressed and slid coaxially onto the distal end of the implantationcatheter 3150. In the pictured embodiment, the wire mesh structure 3121and sleeve 3122 are maintained in their compressed configuration by asuture line or thread 3125 that has been wrapped about both the wiremesh structure 3121 and sleeve. Once the device 3120 has been positionedin the stomach and duodenum of a patient, the suture line or thread 3125is unwound and the wire mesh structure 3121 and sleeve 3122 expand totheir deployed configuration. As the device 3120 expands, it is releasedfrom the catheter 3150. The catheter 3150 is then removed from thepatient. In another embodiment, the compressed wire mesh structure andsleeve are held in place over the implantation catheter via anoverlaying coaxial sheath. Upon deployment, the sheath is eitherunzipped or torn in a vertical direction to release the device.

FIG. 32 is an illustration of an intragastric device 3200 with apartially constrained wire mesh structure 3201 on a delivery catheter3250, in accordance with one embodiment of the present specification.The device 3200 also includes a coupled sleeve 3202 and anti-migrationcomponent 3204. In the pictured embodiment, the proximal end of the wiremesh structure 3201 is still constricted by a suture or thread 3240. Thesleeve 3202, anti-migration component 3204, and a portion of the wiremesh structure 3201 have begun to expand as the constricting suture orthread has already been removed from these components.

FIG. 33A is an illustration of a first exemplary delivery catheter 3350for an intragastric device 3300, in accordance with one embodiment ofthe present specification. An intragastric device 3300, comprising acompressed wire mesh structure 3301 and sleeve 3302, is positionedcoaxially about the distal end of the delivery catheter 3350. A sutureor thread 3340 is wrapped about the device 3300, maintaining the device3300 in its compressed configuration. The catheter 3350 further includesa thread port 3358 from which the suture or thread 3340 used to compressthe intragastric device 3300 exits the proximal end of the catheter3350. A physician pulls on the free end 3359 of the suture or thread3340 to release the intragastric device 3300. In one embodiment, thecatheter 3350 also includes a locking mechanism 3355 for locking thecatheter 3350 in position.

FIG. 33B is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery catheter of FIG. 33A, inaccordance with one embodiment of the present specification. At step3310, a compressed intragastric device is placed coaxially over thedistal end of the delivery catheter. The catheter is then insertedendoscopically into the patient and its distal end is advanced to theduodenum at step 3312. Then, at step 3314, the distal end of thecatheter is positioned such that the wire mesh structure of theintragastric device is in the stomach just proximal to the pylorus andthe sleeve of the device passes through the pylorus and into theduodenum. At step 3316, the physician pulls on the free end of thethread to remove the constricting thread from about the intragastricdevice, allowing the device to expand automatically. Finally, at step3318, the catheter is slid coaxially away from the device and removedfrom the patient.

FIG. 34A is an illustration of a second exemplary delivery catheter 3450for an intragastric device 3400, in accordance with one embodiment ofthe present specification. An intragastric device 3400, comprising acompressed wire mesh structure 3401 and sleeve 3402, is positionedcoaxially about the distal end of the delivery catheter 3450. A zipperedconstraining sheath 3441 is coaxially positioned over the device 3400,maintaining the device 3400 in its compressed configuration.

FIG. 34B is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery catheter of FIG. 34A, inaccordance with one embodiment of the present specification. At step3410, a compressed intragastric device is placed coaxially over thedistal end of the delivery catheter. The catheter is then insertedendoscopically into the patient and its distal end is advanced to theduodenum at step 3412. Then, at step 3414, the distal end of thecatheter is positioned such that the wire mesh structure of theintragastric device is in the stomach just proximal to the pylorus andthe sleeve of the device passes through the pylorus and into theduodenum. At step 3416, a working tool is used to unzip the compressingsheath from about the intragastric device, allowing the device to expandautomatically. Finally, at step 3418, the catheter is slid coaxiallyaway from the device and removed from the patient.

Alternatively, the sheath 3441 is a standard tubular sheath that ispulled off the wire-mesh device to release the wire-mesh device in thedesired position.

FIG. 35A is an illustration of a third exemplary delivery catheter 3550for an intragastric device 3500, in accordance with one embodiment ofthe present specification. An intragastric device 3500, comprising acompressed wire mesh structure 3501 and sleeve 3502, is positionedcoaxially about the distal end of the delivery catheter 3550. Atear-away constraining sheath 3542 is coaxially positioned over thedevice 3500, maintaining the device 3500 in its compressedconfiguration.

FIG. 35B is a flow chart illustrating the steps involved in deliveringan intragastric device using the delivery catheter of FIG. 35A, inaccordance with one embodiment of the present specification. At step3510, a compressed intragastric device is placed coaxially over thedistal end of the delivery catheter. The catheter is then insertedendoscopically into the patient and its distal end is advanced to theduodenum at step 3512. Then, at step 3514, the distal end of thecatheter is positioned such that the wire mesh structure of theintragastric device is in the stomach just proximal to the pylorus andthe sleeve of the device passes through the pylorus and into theduodenum. At step 3516, a working tool is used to tear away acompressing sheath from about the intragastric device, allowing thedevice to expand automatically. Finally, at step 3518, the catheter isslid coaxially away from the device and removed from the patient.

FIG. 35C is a flow chart illustrating the steps involved in delivering awire mesh structure and sleeve separately and assembling an intragastricdevice within a patient's gastrointestinal tract. At step 3560, the wiremesh structure is delivered into the stomach of a patient by a firstcatheter. Then, at step 3562, the sleeve is delivered into the wire meshstructure by a second catheter. The distal end of the sleeve is thenextended through the distal opening in the wire mesh structure at step3564. Finally, at step 3566, the proximal end of the sleeve is coupledto the distal end of the wire mesh structure.

FIG. 36 is an illustration of one embodiment of an intragastric device3600 in a pre-deployment configuration. A catheter 3621 holds thecompressed wire mesh structure 3622. The compressed wire mesh device isheld in place by either a constraining catheter, sheath, or a silksuture or thread. The compressed wire mesh structure 3622 is made ofvertical elements 3623 and horizontal elements 3624. Optionally theintragastric device can be a metal spiral that is cylindrical,comparable to a spring, in constrained positioned and a spiral metalsphere in the deployed shape. In one embodiment, the vertical elements3623 and horizontal elements 3624 comprise a metal. In anotherembodiment, the vertical elements 3623 and horizontal elements 3624comprise an alloy. In another embodiment, the vertical elements 3623 andhorizontal elements 3624 comprise a polymer. In yet another embodiment,the vertical elements 3623 and horizontal elements 3624 comprise a shapememory metal. In yet another embodiment, the vertical elements 3623 andhorizontal elements 3624 comprise a shape memory alloy. In yet anotherembodiment, the vertical elements 3623 and horizontal elements 3624comprise a shape memory polymer. In one embodiment, a weight 3634 ispositioned proximate to the bottom of the intragastric device. Theweight serves to keep the intragastric device in the proper alignmentwhen positioned in the stomach. Preferably, the weight is in a range of1 to 500 grams, preferably between 10 and 50 grams. The catheter 3621has optional ports for passage of wire, contrast or an endoscope locatedin the center of the catheter shaft. One of ordinary skill in the artwould appreciate the structure and configuration of a compressedstructure within a catheter that, after removing a constraining sheath,is permitted to expand at a treatment location.

FIG. 37 is an illustration of another embodiment of an intragastricdevice 3700 in a pre-deployment configuration. A catheter 3721 holds thecompressed wire mesh structure 3722. The compressed wire mesh structure3722 is made of vertical elements 3723 and horizontal elements 3724. Inone embodiment, the vertical elements 3723 and horizontal elements 3724comprise metal. In another embodiment, the vertical elements 3723 andhorizontal elements 3724 comprise an alloy. In another embodiment, thevertical elements 3723 and horizontal elements 3724 comprise a polymer.In yet another embodiment, the vertical elements 3723 and horizontalelements 3724 comprise a shape memory metal. In yet another embodiment,the vertical elements 3723 and horizontal elements 3724 comprise a shapememory alloy. In yet another embodiment, the vertical elements 3723 andhorizontal elements 3724 comprise a shape memory polymer. In oneembodiment, the compressed wire mesh structure 3722 is partiallyenveloped by a membrane 3726. The membrane 3726 is made up of adigestive resistance material.

In one embodiment, the membrane 3726 comprises latex. In anotherembodiment, the membrane 3726 comprises parylene. In another embodiment,the membrane 3726 comprises polyurethane. In another embodiment, themembrane 3726 comprises polytetrafluoroethylene (PTFE). In anotherembodiment, the membrane 3726 comprises fluorinated ethylene-propylene.In another embodiment, the membrane 3726 comprises Dacron. In yetanother embodiment, the membrane 3726 comprises polyethyleneterephthalate (PET). In one embodiment, the membrane 3726 comprisesopenings 3731 proximate the top of the intragastric device 3700 forreceiving chyme and openings 3732 proximate the bottom of theintragastric device 3700 for slow release of the sequestered chyme.

FIG. 38 is an illustration of one embodiment of an intragastric device3800 in a post-deployment configuration. A catheter 3821 is positionedinto the stomach and the compressed wire mesh structure 3822 isreleased. After deployment, the wire mesh structure 3822 assumes itsexpanded configuration. This is achieved through the use of shape memorytechnology as the vertical elements 3823 and horizontal elements 3824expand to assume their pre-defined, post-deployment shapes. Theexpansion of the vertical elements 3823 and horizontal elements 3824creates the spaces 3827 proximate the top of the intragastric device3800 and the spaces 3828 proximate the bottom of the intragastric device3800. These differing sized spaces slow gastric emptying and induce alonger period of satiety.

The spaces within the structure can range in size between 1 μm and 10cm, preferably between 1 mm and 5 cm and most preferably between 5 mmand 10 mm. The spaces at the top of the structure can be same size asthe spaces at the bottom of the structure. Alternatively, in variousembodiments, the spaces at the bottom of the structure are smaller butno smaller than 50% of the larger openings at the top of the structure,otherwise food will accumulate in the device and interfere with itsfunctionality. Alternatively, in one embodiment, the spaces or openingsat the bottom of the structure are larger than the spaces or openings atthe top of the structure. In one embodiment, the gastric emptying isachieved by having each opening at the top have the same surface area aseach opening at the bottom. In this embodiment, the number of openingsat the bottom of the structure will be less than the number of openingsat the top of the structure. If one wished to delay gastric emptying by50%, the number of openings in the bottom will be approximately 50% ofthe number of the openings in the top of the structure. In anotherembodiment, the number of openings at the bottom of the structure isgreater than the number of openings at the top of the structure.Alternatively, the openings at the top can have a larger surface areathan the openings at the bottom and, if one wished to delay gastricemptying by 50%, the total surface area of the openings in the bottomwill be approximately 50% of the total surface area of the openings inthe top of the structure. In another embodiment, the openings at thebottom have a larger surface area than the openings at the top.

After deployment, the catheter 3821 is removed, leaving the deployedintragastric device 3800 in the stomach. The post-deploymentintragastric device 3800 occupies the gastric lumen thereby decreasingthe effective volume available to accommodate ingested food. Thepost-deployment intragastric device 3800 presses upon the gastric wall,stimulating the stretch receptors and inducing the sensation of fullnessor satiety. A sphere is the most effective embodiment of the device asit has the most volume for a given pre-deployment length and surfacearea.

In various possible embodiments, the pre and post-deploymentconfigurations of the intragastric device contain the followingattributes:

Pre-deployment Post-deployment Post-deployment length (cm) radius (cm)volume (cc) 6 1.9 29 9 2.9 98 12 3.8 233 15 4.8 456 18 5.7 787 20 6.41080 25 8.0 2109 30 9.5 3645 40 12.7 8639 50 15.9 16873

The post-deployment radius (r) is equal to pre-deployment length (l)divided by pi (π) and the post-deployment volume (v) is equal to 4 l3/3π2.

FIG. 39 is an illustration of another embodiment of an intragastricdevice 3900 in a post-deployment configuration. A catheter 3921 ispositioned into the stomach and the compressed wire mesh structure 3922is released. After deployment, the wire mesh structure 3922 assumes itsexpanded configuration. This is achieved through the use of shape memorytechnology as the vertical elements 3923 and horizontal elements 3924expand to assume their pre-defined, post-deployment shapes. Theenveloping membrane 3926 gives the intragastric device the quality ofbeing partially permeable to gastric fluids. In the pictured embodiment,holes 3931 are positioned proximate the top of the intragastric device3930 and holes 3932 are positioned proximate the bottom of theintragastric device 30. In one embodiment, the holes 3931 positionedproximate the top of the intragastric device 3930 are larger than theholes 3932 positioned proximate the bottom of the device 3930. Thesediffering sized holes in the membrane 3926 allow for slowing of gastricemptying. After deployment, the catheter 3921 is removed, leaving thedeployed intragastric device 3900 in the stomach. The post-deploymentintragastric device 3900 occupies the gastric lumen thereby decreasingthe effective volume available to accommodate ingested food. Thepost-deployment intragastric device 3900 presses upon the gastric wall,stimulating the stretch receptors and inducing the sensation of fullnessor satiety.

FIG. 40A is an illustration of a gastric device removal catheter 4021attached to an intragastric device 4030 in an exemplary post-deploymentconfiguration. The intragastric device 4030 is depicted in its expanded,spherical shape. A coaxial catheter 4021 is passed through the openingsin the gastric device 4030 and the walls of the device 4030 are engagedby the expanded ends 4064 of the catheter 4021. An inner catheter 4061and outer catheter 4062 are moved in opposite directions resulting inmechanical constriction of the device 4030 to its predominantly linearpre-deployment configuration. In one embodiment, cold fluid 4065 isinstilled into the device 4030 via the catheter 4021 to lower thetemperature of the shape memory structure and assist in furtherconstriction of the device 4030 to its predominantly linearpre-deployment structure.

FIG. 40B is an illustration of a gastric device removal catheter 4021attached to an intragastric device 4030 in an exemplary pre-deploymentconfiguration. The intragastric device 4030 is depicted in itsconstricted, linear shape after constriction of the shape memorystructure via use of the attached gastric device removal catheter 4021.The expanded ends 4064 of the catheter are depicted engaged with theends of the linear intragastric device 4030. The inner catheter 4061 andouter catheter 4062 are depicted after having moved opposite one anotherin order to constrict the intragastric device 4030. The constricted,linear pre-deployment configuration facilitates in the removal of thedevice 4030 from a patient's gastric cavity.

FIG. 41 is an illustration of an intragastric device 4100 being deployedin a stomach 4112. The catheter 4121 used to deliver the intragastricdevice 4100 is depicted as it traverses the esophagus 4111. Thepartially deployed device 4100 is shown in the stomach 4112.

FIG. 42 is an illustration of a fully deployed intragastric device 4200in a stomach 4212. The intragastric device 4200 occupies a significantportion of the stomach 4212, thereby limiting the available volume toaccommodate ingested food. The catheter used for delivery has beenremoved.

FIG. 43A is an illustration of an intragastric device 4330 having anoval shaped wire mesh structure 4331 deployed in the gastrointestinaltract of a patient, in accordance with one embodiment of the presentspecification. In the pictured embodiment, the device 4330 includes awire mesh structure 4331 with a retrieval hook 4333, a coupled sleeve4332, and an anti-migration disc 4334. The device 4330 is deployed suchthat the wire mesh structure 4331 resides in the stomach 4360 with theanti-migration disc 4334 positioned just proximal to the pylorus 4361and the sleeve 4332 extending through the pylorus 4361 and the duodenum4370. The distal end of the sleeve 4332 extends beyond the ampula ofvater 4371. The device 4330 occupies a volume of the stomach 4360, doesnot move entirely past the pylorus 4361, and provides a bypass for foodpast the pylorus 4361, duodenum 4370, and ampula of vater 4371.

FIG. 43B is an illustration of an intragastric device 4340 having afootball shaped wire mesh structure 4341 deployed in thegastrointestinal tract of a patient, in accordance with one embodimentof the present specification. In the pictured embodiment, the device4340 includes a wire mesh structure 4341 with a retrieval mechanism4343, a coupled sleeve 4342, and an anti-migration disc 4344. The device4340 is deployed such that the wire mesh structure 4341 resides in thestomach 4360 with the anti-migration disc 4344 positioned just proximalto the pylorus 4361 and the sleeve 4342 extending through the pylorus4361 and the duodenum 4370. The distal end of the sleeve 4342 extendsbeyond the ampula of vater 4371. The device 4340 occupies a volume ofthe stomach 4360, does not move entirely past the pylorus 4361, andprovides a bypass for food past the pylorus 4361, duodenum 4370, andampula of vater 4371.

FIG. 44 is an illustration of an intragastric device 4400 with anattached sleeve 4440 being deployed over a guidewire 4435 in agastrointestinal tract. The intragastric device 4400 is depicted in thestomach 4412. The attached sleeve 4440 is depicted traveling through thebottom portion of the stomach 4412, passing through the pylorus 4413 andduodenum 4414, and ending and opening up into the jejunum 4420. Food4450 passes through the esophagus 4411 and into the stomach 4412. Thereit enters the intragastric device 4430 through the holes 4431 proximatethe top of the intragastric device 4400. The food 4450 then travels fromthe intragastric device 4440, through the sleeve 4440, and into themiddle portion of the jejunum 4420 without being exposed to the duodenum4414 and proximal jejunum 4420.

FIG. 45 is an illustration of a fully deployed intragastric device 4500with an attached sleeve 4540 in a gastrointestinal tract. Theintragastric device 4500 occupies a significant portion of the stomach4512, thereby limiting the available volume to accommodate ingestedfood. The sleeve 4540 is depicted traveling through the duodenum 4514and into the jejunum 4520, bypassing the duodenum 4514 and ampulla ofvater 4519.

FIG. 46 is an illustration of one single intragastric device 4620 beingpassed over a guidewire 4635 and attached to a previously deployedsingle intragastric device 4630 in a stomach 4612. A catheter 4621 isdepicted passing through the esophagus 4611 and into the stomach 4612.The catheter 4621 is deploying the second single intragastric device4620 and assisting in its attachment to the previously deployedintragastric device 4630. Operationally, the catheter 4621 will bepassed into an opening of the existing intragastric device 4630,preferably the opening used by the original catheter to deploy thedevice. The second device 4620 is then deployed with a portion of thesecond device, such as a neck, protrusion, or other member, fixedlyattached to the first device 4630, thereby anchoring the two devicestogether.

FIG. 47 is an illustration of a fully deployed combined intragastricdevice 4700 in a stomach 4812. The two single intragastric devices 4720,4730 are depicted attached one on top of the other, occupying a greaterstomach 4712 volume than one single intragastric device 4730.

FIGS. 48 and 49 are illustrations of embodiments of an intragastricdevice 4800, 4901 having a first type of circumferential constrainingmechanism 4871 and a second type of circumferential constrainingmechanism 4981, respectively, positioned on a wire mesh structure 4801,4901. Referring to FIGS. 48 and 49 simultaneously, the devices 4800,4900 each comprise a wire mesh structure 4801, 4901, a coupled sleeve4802, 4902, a membrane 4805, 4905 covering the sleeve 4802, 4902 and aportion of the wire mesh structure 4801, 4901, and a plurality ofcircumferential constraining mechanisms 4871, 4981 positioned atdifferent locations about the wire mesh structure 4801, 4901. Thecircumferential constraining mechanisms 4871, 4981 are composed of amaterial that is resistant to degradation by gastric secretions. Theplurality of circumferential constraining mechanisms 4871, 4981 is usedto constrict the wire mesh structure 4801, 4901 into its compressedconfiguration for removal. In one embodiment, an exposed free end ofeach circumferential constraining mechanism 4871, 4981 is pulled via aretrieval device, causing the diameter of each circumferentialconstraining mechanism 4871, 4981 and associated portion of wire meshstructure to decrease.

In one embodiment, each circumferential constraining mechanism comprisesan elongate body having a plurality of pegs or tabs in series and alocking member having a central opening at one end. In one embodiment,the free end 4872, 4982 of each circumferential constraining mechanism4871, 4981 is positioned outside of the wire mesh structure 4801, 4901.In another embodiment (not shown), the plurality of circumferentialconstricting mechanisms have their free ends positioned inside the wiremesh structure. Immediately before retrieval, as the free end 4872, 4982of each circumferential constraining mechanism 4871, 4981 is pulled withthe retrieval device, the pegs or tabs slide through the locking memberand the diameter of the circumferential constraining mechanism 4871,4981 is reduced. The locking member is designed such that pegs or tabsthat have passed through the locking member cannot slide in the reversedirection. In one embodiment, the circumferential constraining mechanism4871, 4981 is a zip tie. In another embodiment, the circumferentialconstraining mechanism 4871, 4981 is a silk suture. The silk sutureincludes a T-tag to maintain the wire mesh structure 4871, 4981 in acompressed configuration once constricted for easy removal. In anotherembodiment, a mechanism applies traction to the silk suture to constrainthe wire mesh structure 4871, 4981 and then a clip or clamp is placed toprevent the silk suture from retracting and releasing the wire meshstructure 4871, 4981. As depicted, in one embodiment, the wire meshstructure 4801, 4901, includes a circumferential constraining mechanism4871, 4981 around its proximal first opening. In one embodiment, thewire mesh structure 4801, 4901, also includes a circumferentialconstraining mechanism 4871, 4981 around its center. In anotherembodiment (not pictured), the wire mesh structure includes acircumferential constraining mechanism at its junction with the sleeve.In various embodiments, the wire mesh structure 4801, 4901 includes asfew as one, two, or more than two circumferential constrainingmechanisms 4871, 4981.

FIG. 50 is an illustration of an intragastric device 5000 being removedfrom a stomach 5012. A catheter 5021 is inserted through the esophagus5011 and attaches to the intragastric device 5000 in the stomach 5012.The catheter 5021 is then used to introduce cold fluid into theintragastric device to lower the temperature of the intragastric device5030, causing the intragastric device 5030 to return its shape back toits pre-deployment configuration. Additional mechanical force can beused to constrain the intragastric device 5030. Once returned to itsinitial compressed cylindrical shape, the intragastric device 5030 canbe removed using the attached catheter 5021.

FIG. 51 is a flow chart illustrating the steps involved during retrievalof an intragastric device in accordance with one embodiment of thepresent specification. At step S102, a physician inserts an endoscopeinto the esophagus of a patient with an implanted intragastric device. Aretrieval device, or forceps, is advanced through the working channel ofthe endoscope at step S104. Then, at step S106, the free end of aconstricting mechanism is grabbed using the forceps. Gentle traction isapplied slowly to draw the constricting mechanism tight and constrictthe wire mesh structure to its compressed configuration at step S108.Steps S106 and S108 are repeated for each remaining constrictingmechanism. Once all the constricting mechanisms have been pulled tight,the device is ready for removal. The forceps are used to grasp theproximal end of the device and the compressed device is removed throughthe working channel of the endoscope at step S110.

FIG. 52 is an illustration of one embodiment of a wire mesh component5201 a of an intragastric device in a post-deployment configurationbeing restrained by circumferential constricting mechanisms 5271 priorto removal. Pulling on the free ends 5272 of the circumferentialconstricting mechanisms 5271 causes them to constrict and lock in place,thereby reducing their diameters and the diameter of the wire meshstructure. Once the wire mesh structure has been constricted to itscompressed configuration 5201 b, it is ready for retrieval. In oneembodiment, the free end 5272 of each circumferential constrictingmechanism 5271 is grabbed by forceps or a grasper passed through theworking channel of an endoscope. Gentle traction is applied slowly toconstrict the wire mesh structure to its compressed configuration 5201b. The free ends 5272 of the constricting mechanisms 5271 are longerafter compression and the wire mesh structure 5201 b has an elongatetubular shape. In various embodiments, the locking mechanisms of the zipties or the T-tags, clips or clamps of the silk sutures prevent the wiremesh structure 5201 b from re-expanding such that the device can beremoved without the need for constant traction to hold the wire meshstructure in the compressed configuration 5201 b. The compressed wiremesh structure 5201 b is then removed through the endoscope.

FIG. 53 is an illustration of one embodiment of a retrieval device 5380and a portion of a wire mesh structure 5301 partially constrained by acircumferential constricting mechanism 5371. In the pictured embodiment,the retrieval device 5380 comprises an elongate body 5381 having aproximal end, a distal end, and a lumen within. An elongate metal wire5383, having a proximal end and a distal end, is disposed within thelumen of the elongate body 5381. A hook 5382 is formed from the distalend of the wire 5383 and an actuator 5384 is attached to the proximalend of the wire 5383. In one embodiment, the actuator 5384 rests in ahandle 5385. A physician manipulates the actuator 5384 to engage thehook 5382 at the distal end of the wire 5383 with the free end 5372 of acircumferential constricting member 5371 positioned on a wire meshstructure 5301. In the pictured embodiment, the circumferentialconstricting mechanism 5371 is a zip tie. The physician pulls on theactuator 5384 to draw the free end 5372 of the circumferentialconstricting mechanism 5371, reducing the diameter of thecircumferential constricting mechanism 5371 and thereby constricting thewire mesh structure 5301, preparing it for retrieval.

FIG. 54 is an illustration of one embodiment of a grasping hook 5482 ofa retrieval device 5480 engaging a tie 5488 that has been secured to theretrieval hook 5404 of a wire mesh structure 5401 of an intragastricdevice. In the pictured embodiment, the tie 5488 has been secured to theretrieval mechanism 5404 to facilitate engagement of the grasping hook5482 with the wire mesh structure 5401. In one embodiment, the tie 5488is secured to the retrieval mechanism 5404 prior to delivery of theintragastric device. In another embodiment, the tie 5488 is secured tothe retrieval mechanism 5404 just prior to retrieval of the intragastricdevice. In another embodiment, the tie 5488 is not used and the graspinghook 5482 directly engages the retrieval mechanism 5404 during deviceretrieval.

FIG. 55A is an illustration of a wire mesh structure 5501 of anintragastric device 5500 partially drawn into the distal end of aretrieval device 5580, in accordance with one embodiment of the presentspecification. The intragastric device 5500 further includes a coupledsleeve 5502 and an anti-migration component 5504. In addition, aretrieval hook 5503 of the intragastric device 5500 is visible insidethe distal end of the retrieval device 5580. The proximal end of thewire mesh structure 5501 also includes a circumferential constrictingmechanism 5571 that has been used to compress the proximal end of thewire mesh structure 5501 to facilitate retrieval by the retrieval device5580.

FIG. 55B is a flow chart illustrating the steps involved in retrieving adeployed intragastric device using the retrieval device of FIG. 54 , inaccordance with one embodiment of the present specification. At stepS510, the retrieval device is inserted endoscopically into a patient andits distal end is advanced to the proximal end of the deployedintragastric device. Then, at step S512, a physician manipulates thegrasping hook of the retrieval device to engage the free end of anautomatically locking circumferential constricting mechanism that ispositioned about the wire mesh structure of the intragastric device. Atstep S514, the physician pulls on the actuator of the retrieval deviceto constrict the automatically locking circumferential constrictingmechanism and compress the wire mesh structure. The physicianmanipulates the grasping hook of the retrieval device to disengage fromthe free end of the circumferential constricting mechanism at step S516.If additional circumferential constricting mechanisms are included aboutthe wire mesh structure, steps S512 through S516 are repeated toconstrict each mechanism. Once all the circumferential constrictingmechanisms have been constricted, the physician then manipulates thegrasping hook of the retrieval device to engage the retrieval mechanismof the intragastric device at step S518. Then, at step S520, thephysician pulls on the actuator to draw the proximal end of theintragastric device into the retrieval device. Finally, at step S522,the retrieval device and intragastric device are removed from thepatient.

FIG. 56A is an illustration of a first exemplary circumferentialconstricting mechanism 5671 in accordance with one embodiment of thepresent specification. The circumferential constraining mechanism 5671comprises an elongate body 5679 having a plurality of pegs or tabs 5675in series, a free end 5672, and a locking member 5673 having a centralopening 5674 at the opposite end.

FIG. 56B is an illustration of the first exemplary circumferentialconstricting mechanism 5671 of FIG. 56A, depicting the circumferentialconstricting mechanism 5671 wrapped about a portion of a wire meshstructure 5601. As the free end 5672 of the circumferential constrainingmechanism 5671 is pulled with a retrieval device, the pegs or tabs 5675slide through the locking member 5673 and the diameter of thecircumferential constraining mechanism 5671 is reduced. The lockingmember 5673 is designed such that pegs or tabs 5675 that have passedthrough the locking member 5673 cannot slide in the reverse direction.

FIG. 57 is an illustration of a second exemplary circumferentialconstricting mechanism 5771 in accordance with one embodiment of thepresent specification. The circumferential constricting mechanism 5771includes an elongate body 5779 having a free end 5772, pegs or tabs5775, and a locking member 5773 having a pair of central openings 5774.

FIG. 58 is an illustration of a third exemplary circumferentialconstricting mechanism 5871 in accordance with one embodiment of thepresent specification. The circumferential constricting mechanism 5871includes an elongate body 5879 having a free end 5872, a plurality ofpairs of pegs or tabs 5875, and a plurality of openings 5874. Thecircumferential constricting mechanism 5871 is locked by passing one ofsaid pairs of pegs or tabs 5875 through one of said openings 5874.

FIG. 59A is an illustration of a fourth exemplary circumferentialconstricting mechanism 5971 in accordance with one embodiment of thepresent specification. The circumferential constricting mechanism 5971includes an elongate body 5979 having a free end 5972, pegs 5975, and alocking member 5973 having a central opening 5974. The circumferentialconstricting mechanism 5971 has an adjustable diameter. The centralopening 5974 of the locking mechanism 5971 includes a first portion 5974a and a second portion 5974 b wherein the diameter of the first portion5974 a is greater than the diameter of the second portion 5974 b. A peg5975 can slide freely through the first portion 5974 a. The elongatebody 5979 fits snugly in the second portion 5974 b of the centralopening 5974 and can be slid horizontally between the first portion 5974a and the second portion 5974 b. The width of the pegs 5975 is greaterthan the diameter of the second portion 5974 b. Therefore, once theelongate body 5979 has been slid horizontally into the second portion5974 b, the pegs 5975 prevent further sliding vertically of the free end5972 within the central opening 5974. The elongate body 5979 can be slidhorizontally back out of the second portion 5974 b and thecircumferential constricting mechanism 5971 can be resized.

FIG. 59B is an illustration of the exemplary circumferentialconstricting mechanism 5971 of FIG. 59A with a portion of the elongatebody slid horizontally into the second section of the central opening5974, thereby locking the circumferential constricting mechanism 5971.

FIG. 60 is an illustration of one embodiment of a retrieval device 6080having a grasping hook 6082 and a grasper 6086 at its distal end. Theretrieval device 6080 comprises an elongate body 6081 having a proximalend, a distal end, and a lumen within. An elongate metal wire 6083,having a proximal end and a distal end, is disposed within the lumen ofthe elongate body 6081. A hook 6082 is formed from the distal end of thewire 6083 and an actuator 6084 is attached to the proximal end of thewire 6083. In one embodiment, the actuator 6084 rests in a handle 6085.The grasper 6086 at the distal end of the retrieval device comprises apair of opposing jaws. In various embodiments, the retrieval device 6080is 5 cm or less in diameter and 50 cm or greater in length. Theretrieval device 6080 is flexible enough to pass through an endoscope. Aphysician manipulates the actuator 6084 to engage the hook 6082 at thedistal end of the wire 6083 with the free end of a circumferentialconstricting mechanism positioned on a wire mesh structure of anintragastric device (not shown).

FIG. 61 is an illustration of one embodiment of a retrieval device 6180with a grasping hook 6182 engaging the free end 6172 of acircumferential constricting mechanism 6171 positioned about a wire meshstructure 6101. The wire mesh structure 6101 is viewed from above andstill in its expanded configuration. In the pictured embodiment, theretrieval device 6180 comprises an elongate body 6181 having a proximalend, a distal end, and a lumen within. An elongate metal wire 6183,having a proximal end and a distal end, is disposed within the lumen ofthe elongate body 6181. A hook 6182 is formed from the distal end of thewire 6183 and an actuator 6184 is attached to the proximal end of thewire 6183. In one embodiment, the actuator 6184 rests in a handle 6185.A physician manipulates the actuator 6184 to engage the hook 6182 at thedistal end of the wire 6183 with the free end 6172 of a circumferentialconstricting mechanism 6171 positioned on the wire mesh structure 6101.In the pictured embodiment, the circumferential constricting mechanism6171 is a suture or thread. The physician pulls on the actuator 6184 todraw the free end 6172 of the circumferential constricting mechanism6171, reducing the diameter of the circumferential constrictingmechanism 6171 and thereby constricting the wire mesh structure 6101.The retrieval device depicted in FIG. 61 further includes a grasper 6186having a pair of opposing jaws. A clamp 6187 is positioned between thejaws of the grasper 6186. Once the wire mesh structure 6101 has beenconstricted to its compressed configuration, the physician manipulatesthe actuator 6184 to close the jaws of the grasper 6186, thereby fixingthe clamp 6187 about the free end of the circumferential constrictingmechanism 6171 proximate the compressed wire mesh structure 6101. Thecircumferential constricting mechanism 6171 is held tightly by the clamp6187 and cannot release so the wire mesh structure 6101 does notre-expand.

FIG. 62 is an illustration of one embodiment of a retrieval device 6280applying a clamp 6287 to a circumferential constricting mechanism 6271positioned about a wire mesh structure 6201 of an intragastric device.The wire mesh structure 6201 is viewed from above and has beenconstricted into its compressed configuration by the circumferentialconstricting mechanism 6271. In the pictured embodiment, the graspinghook 6282 of the retrieval device 6280 is engaged with the free end 6272of the circumferential constricting mechanism 6271. A physician haspulled the actuator 6284 back from the handle 6285 of the retrievaldevice 6280, thereby withdrawing the wire 6283 and moving the graspinghook 6282 in a proximal direction within the lumen of the retrievaldevice body 6281. The free end 6272 of the circumferential constrictingmechanism 6271 is pulled by the grasping hook 6282 into the lumen of theretrieval device body 6281, causing the circumferential constrictingmechanism 6271 to constrict about the wire mesh structure 6201. At thispoint, the physician can manipulate the grasper 6286 at the distal endof the retrieval device 6280 to apply the clamp 6287 to a portion of thefree end 6272 of the circumferential constricting mechanism 6271 that isclosest to the wire mesh structure 6201. Application of the clamp 6287will prevent release of the circumferential constricting mechanism 6271and re-expansion of the wire mesh structure 6201.

FIG. 63 is an illustration of one embodiment of a restrained wire meshstructure 6301 with a clamp 6387 applied to the free end 6372 of acircumferential constricting mechanism 6371 positioned about the wiremesh structure 6301. The wire mesh structure 6301 is viewed from aboveand in its compressed configuration. A majority of the free end 6372 ofthe circumferential constricting mechanism 6371 has been pulledproximally, with respect to the clamp 6387, by a retrieval device asdiscussed with reference to FIG. 63 . This has caused the portion of thecircumferential constricting mechanism 6371 positioned around the wiremesh structure 6301 to decrease in diameter, thereby constricting thewire mesh structure 6301. The clamp 6387 has been applied to a portionof the free end 6372 of the circumferential constricting mechanism 6371proximate the wire mesh structure 6301. The clamp 6387 holds thecircumferential constricting mechanism 6371 in place, keeping the wiremesh structure 6301 compressed and ready for retrieval.

In another embodiment, rather than applying a clamp, the physiciantwists the free end of the circumferential constricting mechanism aboutitself until it holds the wire mesh structure in the compressedconfiguration. In this embodiment, the circumferential constrictingmechanism comprises a flexible metal wire.

In another embodiment, rather than applying a clamp, the physician tiesthe free end of the circumferential constricting mechanism in a knot tohold the wire mesh structure in the compressed configuration. In thisembodiment, the circumferential constricting mechanism comprises a silksuture.

FIG. 64 is a flow chart illustrating the steps involved in retrieving adeployed intragastric device using the retrieval device of FIG. 63 , inaccordance with one embodiment of the present specification. At step6410, the retrieval device is inserted endoscopically into a patient andits distal end is advanced to the proximal end of the deployedintragastric device. Then, at step 6412, a physician manipulates thegrasping hook of the retrieval device to engage the free end of acircumferential constricting mechanism that is positioned about the wiremesh structure of the intragastric device. At step 6414, the physicianpulls on the actuator of the retrieval device to constrict thecircumferential constricting mechanism and compress the wire meshstructure. Then, at step 6416, the physician manipulates the grasper ofthe retrieval device to apply a clamp to the free end of thecircumferential constricting mechanism, proximate the wire meshstructure. At step 6418, the physician pulls on the actuator to draw theproximal end of the intragastric device into the retrieval device.Finally, at step 6420, the retrieval device and intragastric device areremoved from the patient.

FIG. 65A is cross-section illustration of a retrieval device 6500 forremoving an intragastric device in accordance with one embodiment of thepresent specification. The retrieval device 6500 includes a flexiblecatheter 6501 comprising an elongate wire 6505 covered coaxially by asheath. The distal end of the wire 6505 is formed into a hook 6506 forgrasping an intragastric device. The retrieval device 6500 also includesa handle at its proximal end comprising, in one embodiment, a firsthandle component 6514 and a second handle component 6515 that are joinedwith a screw 6520. The handle components 6514, 6515 can be disassembledfor removal of the catheter 6501 from the endoscope or for passage of aflexible overtube 6530 over the wire 6505 and the sheath. The overtube6530 comprises an elongate overtube body 6532 with proximal end, adistal end, and a lumen within, and is used for constraining theintragastric device for final removal out of the body. In oneembodiment, the proximal end of the overtube 6530 includes an adapter6533 configured to attach to component 6515 of the catheter handle. Inone embodiment, wherein the intragastric device includes a wire meshstructure in accordance with the various embodiment of the presentspecification, the mesh is grasped with the wire hook 6506 and then theovertube 6530 is passed over the wire 6505 and sheath. The mesh is thenpulled into the overtube 6530 using the wire hook 6506.

In various embodiments, the overtube 6530 includes an optional port 6537at its proximal end for insufflation of an optional balloon 6536 at thedistal end of the overtube body 6532. The balloon 6536 serves to furtherassist in compression of the intragastric device during removal. In oneembodiment, the overtube 6530 includes a separate, additional lumen influid communication with port 6537 and with the balloon 6536 forinsufflation of said balloon 6536. In one embodiment, the overtube body6532 includes a compartment 6534 at its distal end for holding theballoon 6536 when the balloon is deflated. In various embodiments, theovertube 6530 includes an optional port 6538 at its proximal end forinstillation of cold fluid to facilitate shape change of a temperaturesensitive shape memory mesh. Fluid enters the port 6538, travels throughthe lumen of the overtube body 6532, and exits from the distal end ofthe overtube 6530.

FIGS. 65B and 65C are cross-section illustrations of an exploded viewand assembled view respectively, of the catheter component 6501 of theretrieval device of FIG. 65A. Depicted are the first handle component6514, second handle component 6515, and screw 6520 of the catheterhandle. The handle components attach to the distal end of the wire 6505.The sheath 6510 coaxially covers the wire 6505 and restrains the hook6506 at the distal end of the wire prior to operation of the retrievaldevice.

FIG. 65D is a cross-section illustration of the overtube 6530 of theretrieval device of FIG. 65A, depicting a deflated balloon 6536 at thedistal end of the overtube 6530. In one embodiment, the overtube body6532 includes a compartment 6534 at its distal end for holding theballoon 6536 prior to operation of the retrieval device. The overtube6530 is configured to be slid over the catheter of the retrieval deviceafter the user has grasped the intragastric device with the wire hook ofthe catheter. The user removes the handle of the catheter, slides theovertube 6530 over the catheter, and then reattaches the catheterhandle. The catheter handle is configured to couple with an adapter 6533on the proximal end of the overtube body 6532. The overtube 6530includes an insufflation port 6537 for inflating the balloon 6536. Inone embodiment, the overtube 6530 also includes a port 6538 forinstillation of cold fluid to facilitate a shape change in a temperaturesensitive shape memory intragastric device. FIG. 65E is a cross-sectionillustration of the overtube 6530 of the retrieval device of FIG. 65A,depicting an inflated balloon 6536 at the distal end of the overtube6530. Air or cold saline has been provided at the insufflation port6537, through the overtube body 6530, and into the balloon 6536. Wheninflated, the balloon 6536 emerges from compartment 6534 at the distalend of the overtube body 6530 and assists in compression of theintragastric device into a size manageable for removal from the patient.In one embodiment, the balloon 6536 comprises a thermally conductingmaterial allowing for transfer of cooling energy of a cold fluid fromwithin the balloon 6536 to the intragastric device. The cooling energyassists in the shape change of a temperature sensitive shape memoryintragastric device. Once the intragastric device has been withdrawninto the overtube 6530, the balloon 6536 can be deflated and returned tocompartment 6534 for removal.

FIG. 66 is a flow chart illustrating the steps involved in removing anintragastric device from a patient using the retrieval device of FIG.65A, in accordance with one embodiment of the present specification. Atstep 6602, a physician inserts the catheter component of the retrievaldevice into the working channel of an endoscope that has been insertedinto a patient. The distal end of the endoscope is positioned in thepatient's stomach, proximate the intragastric device. The physician thenmanipulates the wire of the catheter to extend the wire hook beyond thedistal end of the catheter sheath and grasps the intragastric devicewith the wire hook at step 6604. Then, at step 6606, the physicianremoves the catheter handle and slides the overtube component of theretrieval device over the catheter sheath and wire. With the overtube inplace, the physician replaces the catheter handle at step 6608. Then,using the insufflation port, the physician inflates the balloon at thedistal end of the overtube to assist in compression of the intragastricdevice at step 6610. Optionally, at step 6612, the physician installscold water through the overtube, via the instillation port, to assistwith the shape change of a temperature sensitive shape memoryintragastric device. At step 6614, the physician pulls on the wire toretract the compressed intragastric device into the overtube. Finally,at step 6616, the retrieval device and intragastric device therein, areremoved from the patient.

It should be appreciated that the present disclosure is intended toprovide a teaching of several exemplary embodiments of the presentinvention and is should not be limited to the specific structuresdisclosed herein. Other variations of the disclosed embodiments, whichwould be understood by those of ordinary skill, are covered by thepresent application and are within the scope of the invention, asfurther defined by the claims.

I claim:
 1. A medical device comprising: a porous mesh structure comprising a top, a bottom, and an interior and having a pre-deployment shape with a first volume and a substantially ovoid post-deployment shape with a second volume greater than said first volume, wherein, in said post-deployment shape, said porous structure includes at least one first opening proximate said top through which food is configured to enter and at least one second opening proximate said bottom through which the food is configured to exit, such that the food captured by the device is sequestered within the porous mesh structure for a period of time; an anti-migration component positioned proximate said bottom of said porous mesh structure, wherein said anti-migration component comprises a compressed pre-deployment configuration and an expanded post-deployment configuration, wherein said anti-migration component is an extension of said porous mesh structure, and wherein said anti-migration component has a bumper shape where the porous mesh extends distally, curls outward, and extends back proximally; and an elongate sleeve coupled to an outer edge of said anti-migration component.
 2. The medical device of claim 1, wherein the elongate sleeve comprises a flexible elongate body, a proximal end with a third opening, a distal end with a fourth opening, and a sleeve interior, wherein said sleeve is coupled to said porous structure such that food exiting said at least one second opening enters said sleeve through said third opening, passes through said sleeve interior, and exits said sleeve through said fourth opening.
 3. The medical device of claim 2, wherein said at least one first opening does not direct food into said sleeve interior such that food exiting said interior of said porous structure through said at least one first opening does not enter said sleeve and said at least one second opening does direct food into said sleeve interior such that food exiting said interior of said porous structure through said at least one second opening does enter said sleeve.
 4. The medical device of claim 2, wherein a first surface area defined by said at least one first opening is greater than a second surface area defined by said at least one second opening.
 5. The medical device of claim 2, wherein a first surface area defined by said at least one first opening is less than a second surface area defined by said at least one second opening.
 6. The medical device of claim 1, wherein, when in said post-deployment configuration, the diameter of said porous structure is greater than the diameter of an open pylorus.
 7. The medical device of claim 1, wherein the porous structure comprises a wire mesh structure.
 8. The medical device of claim 1, wherein said porous structure is coated with a corrosion-resistant material preventing exposure of said porous structure to gastric acid, further wherein said corrosion-resistant material covers said porous structure and does not cover said openings of said porous structure.
 9. The medical device of claim 8, wherein said corrosion-resistant material comprises any one or combination of silicone, polyester, polyether ether ketone (PEEK), a medical grade epoxy, ceramic, or metal.
 10. The medical device of claim 1, wherein, when in said post-deployment configuration, said anti-migration component has a width that is greater than the diameter of the porous structure.
 11. The medical device of claim 1, wherein, when in said post-deployment configuration, said anti-migration component has a radial strength that is greater than the compressive force of a patient's stomach.
 12. The medical device of claim 1, wherein said anti-migration component is comprised of metal.
 13. The medical device of claim 12, wherein said metal is a shape memory metal.
 14. The medical device of claim 12, wherein said metal is temperature sensitive.
 15. The medical device of claim 1, wherein said anti-migration component is coated with a corrosive resistant material.
 16. The medical device of claim 15, wherein said corrosive resistant material is any one or combination of silicone, polyester, a medical grade epoxy, ceramic, or metal.
 17. The medical device of claim 1, wherein the medical device is an intragastric device. 